BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 21859366 · Received April 17, 2025

    Report

    Report Number
    3023359743-2025-00296
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED SOME PEN NEEDLES ARE HARD TO ATTACH OR CAN'T BE ATTACHED. STATED, PEN NEEDLES ARE HARD TO REMOVE AFTER INJECTIONS FOR THE ONES SHE CAN ATTACH LOT: 4093075. CATALOG: 320119. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32823 PEN NDL 31GA 5MM 100BX 1200 USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320119 4093075 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown