BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 7057389 · Received November 24, 2017

    Report

    Report Number
    MW5073551
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 21, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BARD POWER PORT MEDIPORT IMPLANT PROCEDURE. WIRE WAS KINKED AND COULD NOT USE IT TO IMPLANT DEVICE. NEW KIT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836974 BARD ACCESS SYSTEM POWER PORT LJT BARD ACCESS SYSTEMS REBU0555

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR