BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON MEDICAL PRODUCTS

    MDR report key: 375981 · Received February 7, 2002

    Report

    Report Number
    MW1024024
    Event Type
    Injury
    Date Received
    February 7, 2002
    Date of Event
    January 22, 2002
    Report Date
    January 31, 2002
    Manufacturer
    HORIZON MEDICAL PROD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH INFUSAPORT FOUND TO HAVE APPROX 9.5 CM OF THE DISTAL CATHETER LYING IN THE RIGHT ATRIUM AND VENTRICLE. UNIT REMOVED FROM PT IN TWO SEPARATE PROCEDURES. THE CATHETER WAS REMOVED VIA PERCUTANEOUS VENOUS PUNCTURE IN GROIN. THE INFUS-A-PORT WAS REMOVED SEVERAL DAYS LATER IN THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON MEDICAL PRODUCTS INFUS-A-PORT LJT HORIZON MEDICAL PROD NI 15028

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention