BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 473968 · Received July 23, 2003

    Report

    Report Number
    1056436-2003-00075
    Event Type
    Malfunction
    Date Received
    July 23, 2003
    Date of Event
    July 21, 2003
    Report Date
    July 23, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE USER FACILITY'S OR SUPPLY COORDINATOR INFORMED THE MANUFACTURER'S SALES REPRESENTATIVE OF THE FOLLOWING: BOTH LUMENS FLUSHED WELL PRIOR TO IMPLANT, IMMEDIATELY AFTER BEING IMPLANTED DR. HAD TO REMOVE AND REPLACE WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 17692

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other