BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 18570719 · Received January 24, 2024

    Report

    Report Number
    1920898-2024-05012
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CONSUMER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, THE NEEDLE AND HUB SEPARATED AND IS STUCK INSIDE THE NEEDLE SHIELD. STATED, THERE IS NO EXPIRATION DATE ON THE BAG SHE'S USING AND DOES NOT KNOW HOW OLD THE SYRINGES ARE. 1 SYRINGE AFFECTED. LOT: 0083446. CATALOG: 328509. DATE OF EVENT: 2023-12-26. SAMPLE: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974744 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL Syringe, piston FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328509 0083446 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown