BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 501643 · Received December 1, 2003

    Report

    Report Number
    1710034-2003-00080
    Event Type
    Other
    Date Received
    December 1, 2003
    Date of Event
    September 17, 2003
    Report Date
    October 10, 2003
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 22 GAUGE CATHETER BROKE DURING USE. CATHETER FRAGMENT WAS SUCCESSFULLY REMOVED BY HAND.

    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 3101675

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other