BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1023740 · Received March 26, 2008

    Report

    Report Number
    1710034-2008-00035
    Event Type
    Other
    Date Received
    March 26, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE USED UNIT ON 03/17/2008 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 03/25/2008.

    Description of Event or Problem · 1

    AN INSYTE AUTOGUARD CATHETER BROKE OFF IN THE PATIENT'S HAND AND REQUIRED SURGERY TO REMOVE THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other