BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 549834 · Received July 28, 2004

    Report

    Report Number
    MW1032839
    Event Type
    Malfunction
    Date Received
    July 28, 2004
    Report Date
    July 21, 2004
    Manufacturer
    BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT TO O.R. FIR REMOVAL OF NONFUNCTIONING BARD PORT IMPLANTED PORT. PORT TUBING NOTED TO HAVE BECOME SEPARATED APPROX 4-5 INCHES FROM TIP WITH 2-3 INCHES STILL ATTACHED TO PORT. TUBING REMOVED FROM RIGHT ATRIUM UNDER FLUOROSCOPY USING RIGHT FEMORAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD IMPLANTED PORT (CATHETER & RESERVOIR) LJT BARD 0602230 22GN6016

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR