BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MEDICAL SYSTEMS, INC.

    MDR report key: 556656 · Received October 13, 2004

    Report

    Report Number
    MW1033610
    Event Type
    Malfunction
    Date Received
    October 13, 2004
    Date of Event
    September 21, 2004
    Report Date
    October 5, 2004
    Manufacturer
    BD MEDICAL SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTING IV CATH INTO PT'S VEIN AND RETRACTING NEEDLE, THE HUB OF THE CATH WOULD NOT COME OFF THE HARD PLASTIC NEEDLE GUARD WITHOUT FORCE. IV CATH HAD BEEN TWISTED AROUND PER INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD MEDICAL SYSTEMS, INC. BD INSYTE AUTOGUARD-22 GAUGE IV CATH FOZ BD MEDICAL SYSTEMS, INC. * 4117705

    Patients

    Seq Age Sex Outcome Treatment
    1 *