BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINGERSTIX

    MDR report key: 84953 · Received April 21, 1997

    Report

    Report Number
    MW1011164
    Event Type
    Injury
    Date Received
    April 21, 1997
    Date of Event
    April 12, 1997
    Report Date
    April 14, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 0030 ON 4/12/97, THE NURSE ATEMPTED TO OBTAIN A CAPILLARY BLOOD SPECIMEN FROM THE PT. AFTER SECOND UNSUCCESSFUL ATTEMPT THE NURSE REMOVED THE LANCET TIP AND ENGAGED THE PLUNGER. AGAIN. AT THIS POINT, THE NURSE FELT A STABBING SENSATION TO HER THUMB. SHE WAS WEARING LATEX GLOVES. SHE REPORTS THAT SHE EXAMINED THE LANCET CYLINDER AND WAS FOUND THAT IT WAS BROKEN FROM THE PLASTIC HOUSING OF THE TIP AND STUCK IN THE PLUNGER. THIS PT IS POSITIVE FOR HIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX LANCET FMK BAYER CORP. * 9613811 DEC 96

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention