BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEJET F-16 HEMODIALYSIS CATHETER

    MDR report key: 515771 · Received March 16, 2004

    Report

    Report Number
    1056436-2004-00009
    Event Type
    Injury
    Date Received
    March 16, 2004
    Date of Event
    February 16, 2004
    Report Date
    March 16, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SMALL HOLE IN CATHETER AT HUB AFTER 2-3 WEEKS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEJET F-16 HEMODIALYSIS CATHETER HEMODIALYSIS CATHETER MSD HORIZON MEDICAL PRODUCTS, INC. F16-26-SEK 19662

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention