BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH

    MDR report key: 12083 · Received March 17, 1994

    Report

    Report Number
    MW1001127
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    February 6, 1994
    Report Date
    March 4, 1994
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER FRACTURED AT THE CATHETER HUB AND WAS LEAKING. CATHETER WAS DISCONTINUED AND REMOVED FROM PT. NEW CATHETER WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH L-CATH MIDLING VENOUS CATHETER DQO LUTHER MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other