BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 1218886 · Received October 30, 2008

    Report

    Report Number
    1710034-2008-00140
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON 10/24/2008, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4)

    Description of Event or Problem · 1

    THE INSERTION WAS SUCCESSFUL OF AN L-CATH CATHETER INTO THE SAPHENOUS VEIN OF A PEDIATRIC PT. WHILE PLACING THE TRANSPARENT DRESSING OVER THE DEVICE, THE CATHETER BROKE APPROXIMATELY 5-6 CM AWAY FROM THE STRAIN RELIEF COLLAR. THE CATHETER WAS REMOVED AND A PERIPHERAL IV STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other