BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 482290 · Received September 5, 2003

    Report

    Report Number
    1056436-2003-00079
    Event Type
    Malfunction
    Date Received
    September 5, 2003
    Date of Event
    August 8, 2003
    Report Date
    September 5, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE USER FACILITY INFORMED THE MANUFACTURER VIA A FAXED REPORT OF THE FOLLOWING: CATHETER FRACTURED CLOSE TO PORT, REQUIRED SURGERY FOR REMOVAL AND REPLACEMENT.

    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 15180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR