BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM

    MDR report key: 15163591 · Received August 4, 2022

    Report

    Report Number
    1920898-2022-00511
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 6, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED (24) OPEN 32GX4MM BD PEN NEEDLE WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. THE CUSTOMER REPORTED THAT NO INSULIN FLOWS. THE SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 23 PEN NEEDLES FEATURED A BENT NON-PATIENT END (NPE) CANNULA AND 1 PEN NEEDLE FEATURED A BROKEN NPE CANNULA. THE BENT AND BROKEN NPE CANNULAS WOULD PREVENT PROPER FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED. SINCE ALL 24 SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN) COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT AND BROKEN AFTER THE USER HANDLED THE PEN NEEDLES. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 21 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM WAS UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390145 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 320550 1300018 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown