BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ANGIOGRAPHIC NEEDLE

    MDR report key: 312724 · Received January 16, 2001

    Report

    Report Number
    MW1020826
    Event Type
    Malfunction
    Date Received
    January 16, 2001
    Date of Event
    January 2, 2001
    Report Date
    January 4, 2001
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO FLUSH ANGIOGRAPHIC NEEDLE. NEEDLE NOT USED ON PT YET. NEEDLE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983 ADVANCE ANGIOGRAPHIC NEEDLE ANGIOGRAPHIC NEEDLE S.W. INTRODUCER W/HUB 18 GAUGE X 2 3/4" FMI ADVANCE MEDICAL DESIGNS, INC. 5004 00529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other