BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH

    MDR report key: 11781 · Received February 17, 1994

    Report

    Report Number
    MW1000900
    Event Type
    Malfunction
    Date Received
    February 17, 1994
    Date of Event
    February 4, 1994
    Report Date
    February 4, 1994
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR INSERTED A #18 CATHETER IN LEFT CEPHALIC VEIN. IT WAS IRRIGATED WITH NS WITHOUT DIFFICULTY. WHEN IRRIGATED WITH HEPARIN THE CATHETER STARTED LEAKING AT CONNECTION OF HUB AND CATHETER. IT HAD TO BE REMOVED. NO OTHER VEIN WAS SUITABLE. THIS CATHETER HAD BEEN SENT FREE BY ANOTHER CO'S REP AS A LOT # AND CATHETER THAT MFR HAD SAID WAS SAFE (HAD HAD A PROBLEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PICC DQO LUTHER MEDICAL PRODUCTS, INC. LMP1115

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other