BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIUMPH VTX VASCULAR PORT ACCESS PORT

    MDR report key: 441740 · Received February 7, 2003

    Report

    Report Number
    441740
    Event Type
    Malfunction
    Date Received
    February 7, 2003
    Date of Event
    January 31, 2003
    Manufacturer
    HORIZON MEDICAL PROD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE INSERTED IN 1999. DEVICE WAS NONFUNCTIONAL. ON REMOVAL THE CATH WAS ROUGH, APPEARED ERODED AND FELT LIKE CALCIFICATIONS WHICH REQUIRED ADDITIONAL INCISIONS FOR REMOVAL. THIS TYPE OF CATH HAS BEEN A PROBLEM UPON REMOVAL IN OTHER PTS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH VTX VASCULAR PORT ACCESS PORT CATHETER LJT HORIZON MEDICAL PROD * 16602

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other CHEMOTHERAPY USE.