BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUTHER L-CATH

    MDR report key: 471996 · Received July 11, 2003

    Report

    Report Number
    MW1028976
    Event Type
    Malfunction
    Date Received
    July 11, 2003
    Date of Event
    June 17, 2003
    Report Date
    July 1, 2003
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PIC PLACED IN LEFT SAPHENOUS WITHOUT DIFFICULTY. DURING INITIAL FLUSHING CATHETER NOTED TO HAVE HOLE IN IT AND REMOVED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUTHER L-CATH PIC DQO LUTHER MEDICAL PRODUCTS, INC. * 2344567

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY