BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 473684 · Received July 23, 2003

    Report

    Report Number
    1056436-2003-00071
    Event Type
    Malfunction
    Date Received
    July 23, 2003
    Date of Event
    June 20, 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 06/2003, THE USER FACILITY'S SPEC. TEAM LEADER INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: DEVICE REMOVED IN 2003, MALFUNCTIONED, LEAKING CHEMO OUT AROUND 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 16485

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other