BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1081148 · Received July 11, 2008

    Report

    Report Number
    1081148
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN WAS INSERTING #18 ANGIOCATH. WHEN THE WHITE BUTTON WAS RELEASED FOR RETRACTION OF THE NEEDLE, BLOOD FLEW INTO THE BOTTOM OF THE PLASTIC CONTAINER AND SQUIRTED OUT OF THE HOLE IN THE BOTTOM OF THE PLASTIC CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, IV, SAFETY FOZ BECTON DICKINSON REF381444 7352356

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES