BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEMS, INC

    MDR report key: 1347384 · Received March 19, 2009

    Report

    Report Number
    MW5010423
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 19, 2009
    Manufacturer
    BARD ACCESS SYSTEMS INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: PORT-A-CATCH INSERTION WITH C-ARM FLUOROSCOPY. ACCORDING TO THE SURGEON, THE TIP ON THE CATHETER WAS DEFECTIVE - NO SPECIFICS GIVEN- AND HE USED ANOTHER PACKAGE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS, INC BARDPORT TITANIUM DOME IMPLANTED PORT LJT BARD ACCESS SYSTEMS INC 0602850 RESL0483

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR