BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 6 MM 1/4 TIP

    MDR report key: 23341586 · Received October 20, 2025

    Report

    Report Number
    MW5177649
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Report Date
    October 13, 2025
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER PARENT OF THE PT: I PUT THE NEEDLE IN THE PEN AND APPLIED THE MEDICATION TO IT. WHEN I TRIED TO REMOVE THE NEEDLE, I SAW THAT IT WAS STUCK. IT GOT TANNED IN THE PEN AND DIDN'T COME OUT AT ALL. I PUSHED A LOT AND THEN WHEN IT FINALLY CAME OUT I SAW THAT THE PEN WAS DAMAGED. NO FURTHER INFO. UNKNOWN IF DEVICE ON HAND FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451593 PEN NEEDLE 32G 6 MM 1/4 TIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male