BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBCUTANEOUS PORT VAD

    MDR report key: 14650 · Received July 13, 1994

    Report

    Report Number
    MW1002796
    Event Type
    Other
    Date Received
    July 13, 1994
    Date of Event
    June 23, 1994
    Report Date
    June 29, 1994
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATH (VAD) IMPLANTED IN LEFT SUBCLAVIAN AREA. WHEN X-RAY WAS REQUESTED TO CHECK PLACEMENT, IT WAS NOT VISIBLE ON SCREEN. CONRAY DYE WAS INTRODUCED, WAS ABLE TO BE SEEN ON X-RAY AND HAD BLOOD RETURN. WHEN PORT WAS SUTURED UNDER SKIN, NEEDLE INTRODUCED; NO BLOOD RETURN. X-RAY TAKEN; NOT SEEN ON SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBCUTANEOUS PORT VAD Implant SUBCUTANEOUS PORT VAD LJT BARD ACCESS SYSTEMS, INC. 36CE9813

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other