ETALON Russian Company Limited Liability Company (ETALON Russian Company LLC), 20 Kulakova Street, Building 1, Floor 4, Office 403, 123592, Moscow, Russian Federation; TIN 7734429967; PSRN 1197746595090; acting as the authorized representative of the manufacturer Pikdare S.p.A., Italy, in the territory of the Russian Federation, hereby reports in response to the letter from the Federal Service for Surveillance in Healthcare (Roszdravnadzor) No. 10-14644/25 dated 17 March 2025.
A report of an adverse event dated 20 November 2024, No. NS-15615, concerning a safety issue involving the medical device “INSUPEN Disposable Pen Needles,” Registration Certificate No. FSZ 2011/09838 dated 27 April 2024, was received in the Roszdravnadzor AIS database.
In this regard, ETALON Russian Company LLC is providing a corrective action report in accordance with Appendix No. 3 to Order No. 1113n of the Ministry of Health of Russia dated 19 October 2020 (Appendix 1), as well as a medical device safety notice in accordance with Appendix No. 4 to Order No. 1113n of the Ministry of Health of Russia dated 19 October 2020, intended for users of the medical device “INSUPEN Disposable Pen Needles” (Appendix No. 2). These documents have been published on the ETALON Russian Company LLC website.
We would also like to inform you that INSUPEN Disposable Pen Needles are manufactured from high-quality materials. The manufacturing process complies with European standards and is supported by an ISO 13485-certified quality management system, as confirmed by the relevant certificate. Each batch of needles undergoes mandatory quality control before being released for circulation.
To minimize the risk of improper use and, consequently, adverse events, users must read the instructions for use. Failure to comply with storage conditions or improper or repeated use of the needles may result in deterioration of needle quality.
According to a survey conducted by the Russian Diabetes Association, patients frequently fail to comply with the recommended single-use requirement for insulin needles: patients reuse insulin needles because of an acute shortage of needles. According to public diabetes organizations, patients in the regions do not receive needles in sufficient quantities. The needles are intended for single use; reuse causes the needle to deform and become clogged. Using a deformed needle can lead to lipohypertrophy, increased pain and skin damage. A clogged needle prevents administration of the medicinal product.
Selecting the correct needle size, following the injection technique described in the instructions, and checking the integrity of the packaging and the needle itself before use makes it possible to eliminate the risks of adverse events associated with the use of the needles.
Appendix No. 1 – Corrective Action Report in accordance with Appendix No. 3 to Order No. 1113n of the Ministry of Health of Russia dated 19 October 2020.
Appendix No. 2 – Medical Device Safety Notice in accordance with Appendix No. 4 to Order No. 1113n of the Ministry of Health of Russia dated 19 October 2020.
Corrective Action Report on Medical Device Safety
1. Information on the entity involved in the circulation of medical devices:
a) ETALON Russian Company Limited Liability Company (ETALON Russian Company LLC), 20 Kulakova Street, Building 1, Floor 4, Office 403, 123592, Moscow, Russian Federation, tel.: 8 (495) 781 85 95, email address: all@companyetalon.com. Official website of ETALON Russian Company LLC: https://company-etalon.com/.
b) TIN 7734429967;
c) PSRN 1197746595090;
d) Limited liability company.
2. Information on the medical device in relation to which the adverse event was identified:
a) Name of the medical device according to the registration certificate: “INSUPEN Disposable Pen Needles”;
b) Registration Certificate No. FSZ 2011/09838 dated 19 September 2022;
c) Potential risk class: 2a;
d) Medical device type code and name according to the nomenclature classification of medical devices approved by Order No. 4n of the Ministry of Health of the Russian Federation dated 6 June 2012, registered by the Ministry of Justice of the Russian Federation on 9 July 2012, Registration No. 24852: 137610, Needle for an autoinjector;
e) Catalogue item for goods, works and services to meet state and municipal needs, in accordance with the Rules for the Formation and Maintenance of the Catalogue of Goods, Works and Services to Meet State and Municipal Needs in the Unified Information System in the Procurement Sector and the Rules for Using the Catalogue approved by Resolution No. 145 of the Government of the Russian Federation dated 8 February 2017: 32.50.13.110-00005038;
f) Name of the medical device manufacturer according to the registration certificate: Pikdare S.p.A., Italy, Casnate con Bernate (CO), Via Saldarini Catelli, 10, CAP 22070, Italy;
g) Country of manufacture of the medical device according to the registration certificate: Italy;
h) Address(es) of the manufacturing site(s) of the medical device according to the registration certificate: Pikdare S.p.A., Via Saldarini Catelli, 10, 22070 Casnate con Bernate, Como, Italy;
i) Lot number: 2204768;
j) Number of medical devices in circulation, including the relevant lot numbers and serial numbers, in relation to which the adverse event was identified: 2 units;
k) Date of manufacture: 01 April 2022;
l) Shelf life/service life of the medical device: 5 years;
m) Expiry date or end date of the warranty period, operating period or service life established by the manufacturer: 01 April 2027;
n) Country, constituent entity of the Russian Federation, locality and address where the adverse event occurred: State Autonomous Healthcare Institution “Rezh Central District Hospital,” Sverdlovsk Region, Rezh, 60 Pavlika Morozova Street;
o) Location of the medical device at the time the adverse event report was submitted (disposed of, transferred to a quarantine area, transferred to the supplier or manufacturer of the medical device or its authorized representative, still in use, other): disposed of;
p) Number of medical devices involved in the adverse event: 2 units.
3. Description of the adverse event:
a) Date on which information about the adverse event was submitted to the Federal Service for Surveillance in Healthcare: 20 November 2024;
b) Type of adverse event notification related to the use of the medical device (initial, follow-up or final): initial;
c) Type of adverse event report related to the use of the medical device (initial, follow-up or final): follow-up final;
d) Date on which information about the adverse event was received: 20 November 2024;
e) Date of the adverse event: 21 October 2024;
f) Adverse event registration number assigned by the manufacturer, if available: NS-15615;
g) Type and category of the adverse event according to the reference classifier of adverse events, adverse reactions associated with the use of medical devices, and facts and circumstances posing a threat of harm to human life and health during the circulation of registered medical devices: material fragmentation (2005);
h) Medical device user (physician, nurse, patient or other): patient;
i) Use of the medical device (initial use, repeated use of a single-use medical device, use of a reusable medical device, medical device used after maintenance or repair, problem identified before use, other): initial use;
j) Category of the adverse event associated with the use of the medical device: inadequate quality of the medical device.
4. Information on the injured person:
a) Injured person: patient at home;
c) Sex, age, weight and height: female;
d) Severity criterion (harm caused): threat to health;
e) Outcome: recovery without consequences;
f) Description of the problem experienced by the injured person: one needle became lodged in the abdominal skin; the second needle broke;
h) Number of injured persons, if known: 1;
i) Actions and assistance provided to the injured person by the medical organization: none.
5. Additional information:
a) Preliminary conclusion and analysis by the manufacturer or its authorized representative: INSUPEN Disposable Pen Needles are manufactured from high-quality materials. The manufacturing process complies with European standards and is supported by an ISO 13485-certified quality management system, as confirmed by the relevant certificate.
Each batch of needles undergoes mandatory quality control before being released for circulation. However, following identification of the adverse event, ETALON Russian Company LLC sent a request to the manufacturer to conduct an internal investigation, verify the quality of needles from lot 2204768 with an expiry date of 01 April 2027, and provide the results of the final inspection of the lot.
To minimize the risk of improper use and, consequently, adverse events, users must read the instructions for use. Failure to comply with storage conditions or improper or repeated use of the needles may result in deterioration of needle quality.
b) Initial corrective actions taken by the manufacturer:
ETALON Russian Company LLC suspended the circulation of the medical device “INSUPEN Disposable Pen Needles,” lot No. 2204768.
ETALON Russian Company LLC sent a request to the State Autonomous Healthcare Institution “Rezh Central District Hospital,” which had reported the adverse event, for the samples associated with the adverse events and detailed information about the incident (outgoing letter No. 241126-462/1 dated 27 November 2024); no response was received.
ETALON Russian Company LLC sent a request to the manufacturer to conduct an internal investigation and verify the quality of needles from lot 2204768 with an expiry date of 01 April 2027.
c) Results of the manufacturer’s final investigation analysis, for the final report:
Because the samples associated with the adverse events and detailed information about the incident were not received from the State Autonomous Healthcare Institution “Rezh Central District Hospital,” the manufacturer of the needles, Pikdare S.p.A., Italy, conducted testing on control samples from lot 2204768. A review of the production and lot-release documentation revealed no deviations either at the preliminary cannula manufacturing stage or during the subsequent needle assembly and packaging stages. In fact, none of the various inspections revealed any deviations related to the steel or the finished product. Pen needles are manufactured in accordance with ISO 9626:2016.
To complete the assessment, a breakage test was performed on control samples from lot 2204768. The test consists of subjecting the needles to a specified number of bending cycles to identify any weak points that could lead to cannula breakage, following the method required by ISO 9626:2016.
The breakage test was performed on 10 samples, in accordance with ISO 2859-1; no signs of breakage were detected in the samples.
In addition, cannula stiffness was tested on 10 other control samples from lot 2204768 in accordance with an internal procedure. The components complied with ISO 9626:2016, and the wall stiffness met the product specification.
Based on the manufacturer’s experience and the tests performed, the breakage was caused by improper use of the needles by the user. In particular, it may have resulted from:
· an incorrectly selected needle angle in relation to the skin;
· excessive force applied during the injection;
· repeated use of the needle;
· sudden movement by the patient during the injection.
The needles are intended for single use; reuse causes the needle to deform and become clogged.
Selecting the correct needle size, following the injection technique described in the instructions, and checking the integrity of the packaging and the needle itself before use makes it possible to eliminate the risks of adverse events associated with the use of the needles.
d) Number of similar adverse events involving the same type of medical device, with a similar cause and type according to the Adverse Event Classifier, known to the manufacturer or its authorized representative: none identified previously;
e) Recommendations for users:
· use the needles only once;
· select the correct needle size, follow the injection technique described in the instructions, and check the integrity of the packaging and the needle itself before use to eliminate the risks of adverse events associated with the use of the needles.
Medical Device Safety Notice
1. Information on the entity involved in the circulation of medical devices:
a) ETALON Russian Company Limited Liability Company (ETALON Russian Company LLC), 20 Kulakova Street, Building 1, Floor 4, Office 403, 123592, Moscow, Russian Federation, tel.: 8 (495) 781 85 95, email address: all@companyetalon.com. Official website of ETALON Russian Company LLC: https://company-etalon.com/.
b) TIN 7734429967;
c) PSRN 1197746595090;
d) Limited liability company.
2. Information on the medical device in relation to which the adverse event was identified:
a) Name of the medical device according to the registration certificate: “INSUPEN Disposable Pen Needles”;
b) Registration Certificate No. FSZ 2011/09838 dated 19 September 2022;
c) Potential risk class: 2a;
d) Medical device type code and name according to the nomenclature classification of medical devices approved by Order No. 4n of the Ministry of Health of the Russian Federation dated 6 June 2012, registered by the Ministry of Justice of the Russian Federation on 9 July 2012, Registration No. 24852: 137610, Needle for an autoinjector;
e) Catalogue item for goods, works and services to meet state and municipal needs, in accordance with the Rules for the Formation and Maintenance of the Catalogue of Goods, Works and Services to Meet State and Municipal Needs in the Unified Information System in the Procurement Sector and the Rules for Using the Catalogue approved by Resolution No. 145 of the Government of the Russian Federation dated 8 February 2017: 32.50.13.110-00005038;
f) Name of the medical device manufacturer according to the registration certificate: Pikdare S.p.A., Italy, Casnate con Bernate (CO), Via Saldarini Catelli, 10, CAP 22070, Italy;
g) Country of manufacture of the medical device according to the registration certificate: Italy;
h) Address(es) of the manufacturing site(s) of the medical device according to the registration certificate: Pikdare S.p.A., Via Saldarini Catelli, 10, 22070 Casnate con Bernate, Como, Italy;
i) Lot number: 2204768;
j) Date of manufacture: 01 April 2022;
k) Shelf life/service life of the medical device: 5 years;
l) Expiry date or end date of the warranty period, operating period or service life established by the manufacturer: 01 April 2027;
m) Number of medical devices involved in the adverse event: 2 units.
3. Additional information:
a) Type of corrective action (suspension of use of the medical device, replacement of the medical device by the manufacturer or its authorized representative, return of the medical device to the manufacturer or its authorized representative, destruction of the medical device, change in the properties and characteristics affecting the quality, performance and safety of the medical device, improvement of its properties and characteristics without changing the intended purpose and/or operating principle of the medical device, including changes to the instructions for use or operating manual, software update, other) (for the safety notice):
ETALON Russian Company LLC suspended the circulation of the medical device “INSUPEN Disposable Pen Needles,” lot No. 2204768.
ETALON Russian Company LLC sent a request to the State Autonomous Healthcare Institution “Rezh Central District Hospital,” which had reported the adverse event, for the samples associated with the adverse events and detailed information about the incident (outgoing letter No. 241126-462/1 dated 27 November 2024); no response was received.
ETALON Russian Company LLC sent a request to the manufacturer to conduct an internal investigation and verify the quality of needles from lot 2204768 with an expiry date of 01 April 2027.
The manufacturer of the needles, Pikdare S.p.A., Italy, conducted testing on control samples from lot 2204768. A review of the production and lot-release documentation revealed no deviations either at the preliminary cannula manufacturing stage or during the subsequent needle assembly and packaging stages. In fact, none of the various inspections revealed any deviations related to the steel or the finished product. Pen needles are manufactured in accordance with ISO 9626:2016.
To complete the assessment, a breakage test was performed on control samples from lot 2204768. The test consists of subjecting the needles to a specified number of bending cycles to identify any weak points that could lead to cannula breakage, following the method required by ISO 9626:2016.
The breakage test was performed on 10 samples, in accordance with ISO 2859-1; no signs of breakage were detected in the samples.
In addition, cannula stiffness was tested on 10 other control samples from lot 2204768 in accordance with an internal procedure. The components complied with ISO 9626:2016, and the wall stiffness met the product specification.
Based on the manufacturer’s experience and the tests performed, the breakage was caused by improper use of the needles by the user. In particular, it may have resulted from:
· an incorrectly selected needle angle in relation to the skin;
· excessive force applied during the injection;
· repeated use of the needle;
· sudden movement by the patient during the injection.
The needles are intended for single use; reuse causes the needle to deform and become clogged.
Selecting the correct needle size, following the injection technique described in the instructions, and checking the integrity of the packaging and the needle itself before use makes it possible to eliminate the risks of adverse events associated with the use of the needles.
b) Description of the problem (for the safety notice): one needle became lodged in the abdominal skin; the second needle broke;
c) Description of the actions to be taken by the medical device user (for the safety notice):
· use the needles only once;
· select the correct needle size, follow the injection technique described in the instructions, and check the integrity of the packaging and the needle itself before use to eliminate the risks of adverse events associated with the use of the needles.
d) Contact information for inquiries regarding this specific safety notice (organization name, postal address, telephone number, email address): ETALON Russian Company LLC, postal address: 20 Kulakova Street, Building 1, Floor 4, Office 403, 123592, Moscow, Russian Federation; telephone: 8 (495) 781 85 95; email address: all@company-etalon.com.