BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDPORT TITANIUM LOW PROFILE IMPLANTABLE PORT

    MDR report key: 4890865 · Received July 3, 2015

    Report

    Report Number
    4890865
    Event Type
    Malfunction
    Date Received
    July 3, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 3, 2015
    Manufacturer
    BARD ACCESS SYSTEMS, INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PLACING AN IV PORT. BEFORE INTRODUCING IT, NOTED A BARB PRESENT IN THE END OF THE INTRODUCER. THIS WAS NOT USED - ANOTHER PORT AND INTRODUCER WERE USED AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433902 BARDPORT TITANIUM LOW PROFILE IMPLANTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC * REYJO411

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR