BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 FRENCH IMPLANTABLE PORT

    MDR report key: 5515863 · Received March 17, 2016

    Report

    Report Number
    MW5061011
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 18, 2016
    Report Date
    March 17, 2016
    Manufacturer
    BARD ACCESS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A 8 FRENCH IMPLANTABLE PORT REF # (B)(4), FROM THE BARD ACCESS SYSTEMS, OUT OF (B)(6), IMPLANTED AND THERE WAS A MALFUNCTION OF THE PRODUCT. WHILE GOING THROUGH CHEMOTHERAPY, THE PRODUCT WAS IMPLANTED IN THE BODY, HAD SURGERY TO HAVE THE PRODUCT REMOVED, THE PRODUCT BROKE IN THREE PIECES, HAD A LITTLE TEARING OF THE ARTERY WHILE FISHING FOR THE PRODUCT. IT LEFT A SUPERFICIAL BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163394 8 FRENCH IMPLANTABLE PORT IMPLANTABLE PORT LJT BARD ACCESS REF#0602830

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R