BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15693578 · Received October 28, 2022

    Report

    Report Number
    1920898-2022-00752
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 4, 2022
    Report Date
    January 5, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: 09-NOV-2022 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (10) 0.5ML, 31 GAUGE, 8MM SYRINGES FROM LOT 2010796. A VISUAL INSPECTION OF THE RETURNED SYRINGES FOUND THAT 3 HAD BENT NEEDLES. THESE NEEDLES WERE BENT AT THEIR BASES, THOUGH THE DEGREES TO WHICH THEY WERE BENT WERE NOT SIGNIFICANT ENOUGH TO INTERFERE WITH THE NEEDLE SHIELD. EACH SYRINGE WAS THEN MECHANICALLY TESTED. WATER WAS DRAWN INTO AND EXPELLED FROM EACH OF THE SYRINGES. NONE OF THE SYRINGES WERE FOUND TO LEAK. WHILE SOME OF THE SYRINGES WERE FOUND TO HAVE BENT, THE SYRINGES OTHERWISE FUNCTIONED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2010796. 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 SYRINGES LEAKING. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN TAKING INJECTION, MEDICATION LEAKS OUT AROUND HUB STATED, HER NUMBERS HAVE BEEN HIGH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN TAKING INJECTION, MEDICATION LEAKS OUT AROUND HUB STATED, HER NUMBERS HAVE BEEN HIGH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868346 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 2010796 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown