BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIUMPH-1 PORT

    MDR report key: 456808 · Received April 29, 2003

    Report

    Report Number
    1056436-2003-00035
    Event Type
    Malfunction
    Date Received
    April 29, 2003
    Date of Event
    March 28, 2003
    Report Date
    April 29, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 04/2003 THE USER FACILITY'S OR EQUIPMENT SPECIALIST INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: WOULD NOT FLUSH, OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 PORT VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other