BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PORT

    MDR report key: 2854195 · Received November 8, 2012

    Report

    Report Number
    2854195
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH IMPLANTED APPROXIMATELY 8 MONTHS AGO. UNDER FLUOROSCOPY, A DISRUPTION OF THE TUBING WAS SEEN IN THE MIDPORTION WHERE THERE WAS A KINK WITH EXTRAVASATION OF CONTRAST. THE DEVICE REMAINS IN THE PATIENT; IT HAS NOT BEEN REMOVED. THE MANUFACTURER HAS BEEN NOTIFIED. WE HAVE BEEN WORKING WITH THE MANUFACTURER FOR A FEW YEARS TO HELP US UNDERSTAND WHY WE HAVE SO MANY CRACKED CATHETERS: WE ARE REGULARLY SEEING THIS KIND OF EVENT. AT THIS TIME, THE CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR