BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERSTIX

    MDR report key: 187397 · Received September 9, 1998

    Report

    Report Number
    1810909-1998-00007
    Event Type
    Malfunction
    Date Received
    September 9, 1998
    Date of Event
    July 26, 1998
    Report Date
    September 8, 1998
    Manufacturer
    BAYER CORP
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF FINGER STICK, A NURSE WAS STUCK WITH A LANCET AFTER PLACING THE USED FINGERSTIX IN THE PALM OF HER HAND. THE DESIGN OF THE FINGERSTIX SYSTEM IS TO HAVE THE LANCET RETRACT SAFELY INTO THE END CAP, PREVENTING AN INADVERTENT PUNCTURE. THE PT IN WHICH THE DEVICE WAS USED WAS CLASSIFIED AS LOW RISK IN REGARDS TO TRANSMITTABLE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX BLOOD LETTING DEVICE FMK BAYER CORP 5965 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN