BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1002946 · Received February 6, 2008

    Report

    Report Number
    1710034-2008-00012
    Event Type
    Other
    Date Received
    February 6, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS BEING SENT FOR INVESTIGATION FROM THE CUSTOMER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 05 FEBRUARY 2008.

    Description of Event or Problem · 1

    THE CATHETER BROKE AND THE PATIENT REMOVED IT. APPROXIMATELY, ONE THIRD OF THE CATHETER WAS MISSING FROM THE TIP AND IT WAS NEVER FOUND.

    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 AN 7143103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other