BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAYER, FINGERSTIX

    MDR report key: 520634 · Received March 31, 2004

    Report

    Report Number
    MW1031541
    Event Type
    Other
    Date Received
    March 31, 2004
    Date of Event
    March 22, 2004
    Report Date
    March 31, 2004
    Manufacturer
    BAYER CORP
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN WAS ADMINISTERING BLOOD GLUCOSE TESTING WITH BAYER LANCING DEVICE AND LANCET. LANCET IS SUPPOSED TO HAVE SAFETY FEATURE WHEREBY NEEDLE INSIDE RETRACTS AND REMAINS RECESSED AFTER ACTIVATION. RN HAD DEVICE IN THEIR HAND AND NEEDLE INSIDE PUNCTURED THEIR FINGER, NEEDLE WAS NOT RECESSED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER, FINGERSTIX GLUCOMETER LANCET FMK BAYER CORP 5965 J115A13
    2 BAYER, FINGERSTIX GLUCOMETER LANCET FMK BAYER CORP 5965 J317111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other