BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDPORT

    MDR report key: 2022605 · Received March 4, 2011

    Report

    Report Number
    2022605
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING PORT WAS REMOVED. ACCORDING TO THE SURGEON, IT WAS LEAKING. NOTES FROM THE HISTORY AND PHYSICAL:"RECENTLY SHE DEVELOPED SOME SYMPTOMS INCLUDING PAIN AND SWELLING WITH ACCESS AND INJECTION OF THE PORT. A PORTOGRAM DEMONSTRATED A LEAK IN THE PROXIMAL PORTION OF THE CATHETER AND SHE NOW PRESENTS FOR REMOVAL OF THAT CATHETER." NOTES FROM THE OPERATIVE REPORT. "THE PORT WAS EXAMINED. I DID NOT SEE ANY OBVIOUS CRACK OR EROSIONS IN THE CATHETER." THERE WERE NO COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT CATHETER, PORT, IMPLANTED LJT BARD ACCESS SYSTEM 0605420 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR CARDIAC DRUGS