BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT

    MDR report key: 218858 · Received April 15, 1999

    Report

    Report Number
    218858
    Event Type
    Injury
    Date Received
    April 15, 1999
    Date of Event
    February 25, 1999
    Report Date
    March 17, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIAL PORT CATH WAS PLACED 03/06/1997. ON 02/24/1999, UNABLE TO FLUSH CATHETER. CHEST X-RAY SHOWED FRACTURED CATHETER IN SUPERIOR VENA CAVA, PEEKING INTO RIGHT ATRIUM. PT WAS ASYMPTOMIC. ON 02/25/1999, CATHETER REMOVED INTACT VIA RIGHT FEMORAL VEIN APPROACH. ON 03/12/1999, THE BOTTOM PORTION OF THIS APPARATUS WAS REMOVED, THIS FACILITY WILL ALSO FILE A REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT Implant IV CATHETER. LJT HORIZON MEDICAL PRODUCTS, INC. UNK 13879

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention UTILIZING FOR ADMINISTRATION OF CHEMOTHERAPY.