BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PORT M.R.I. IMPLANTABLE PORT

    MDR report key: 3233853 · Received July 12, 2013

    Report

    Report Number
    MW5030912
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANTATION OF BARD POWER PORT THE "J" TIP GUIDEWIRE WAS NOTED TO BE FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321667 POWER PORT M.R.I. IMPLANTABLE PORT POWER PORT LJT BARD ACCESS SYSTEMS 1808000 REXD1410

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR