BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPORT IMPLANTABLE PORT

    MDR report key: 8776838 · Received July 9, 2019

    Report

    Report Number
    MW5087985
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LINE IN MY "POWERPORT" IMPLANTABLE PORT FRACTURED AND LEAKED WHEN SALINE SOLUTION WAS INJECTED TO IT DURING A ROUTINE INFUSION. MY POWERPORT MADE BY BARD ACCESS SYSTEMS, INC, (B)(4), WAS INSTALLED IN MY CHEST ON (B)(6) 2017 BY DR (B)(6). HAD TO HAVE "PORT-SCAN" TEST. POWERPORT REF # 1808000, LOT = REAX1808. PORT SCAN WAS CONDUCTED AT (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568046 POWERPORT IMPLANTABLE PORT PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC. REF# 1808000 REAX1808

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other