BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE 3/10ML 29G X 8MM

    MDR report key: 15874978 · Received November 28, 2022

    Report

    Report Number
    1920898-2022-00825
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 2, 2022
    Report Date
    February 2, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-JAN-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (17) 0.3ML, 31 GAUGE, 8MM SYRINGES FROM LOT 2122331. ALL SAMPLES RECEIVED SHIELD PULL FORCE TESTING. THE PULL FORCES REQUIRED TO REMOVE THE NEEDLE SHIELDS IS DOCUMENTED BELOW: 1. 5.07 LBS 2. 4.24 LBS 3. 4.33 LBS 4. 2.83 LBS 5. 4.58 LBS 6. 3.41 LBS 7. 2.96 LBS 8. 3.66 LBS 9. 4.85 LBS 10. 4.24 LBS 11. 4.51 LBS 12. 4.41 LBS 13. 4.82 LBS 14. 3.23 LBS 15. 3.98 LBS 16. 4.26 LBS 17. 3.41 LBS THE SPECIFICATION STATES THAT ALL PULL FORCES WITHIN THE RANGE OF 0.85 LBS TO 5.95 LBS ARE ACCEPTABLE. NONE OF THE SAMPLES TESTED OUTSIDE OF THE REQUIRED RANGE AND NONE OF THE SAMPLES DISASSEMBLED DURING TESTING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2122331. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE HUB SEPARATING. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE HUB SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE STATED THAT THE NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND ONCE REMOVED, THE NEEDLE HUB SEPARATES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE HUB SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE STATED THAT THE NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND ONCE REMOVED, THE NEEDLE HUB SEPARATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677371 RELION INSULIN SYRINGE 3/10ML 29G X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 2122331 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown