BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 479435 · Received August 18, 2003

    Report

    Report Number
    1710034-2003-00056
    Event Type
    Other
    Date Received
    August 18, 2003
    Date of Event
    June 16, 2003
    Report Date
    June 24, 2003
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO ACTIVATE THE 20 GAUGE DEVICE. THE NURSE ATTEMPTED TO ACTIVATE THE 20 GAUGE DEVICE AND WAS UNSUCCESSFUL RESULTING IN A NEEDLESTICK INJURY. THE DEVICE ACTIVATED WHEN DISPOSED IN A SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 3036835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other