BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATHETER KIT

    MDR report key: 3852940 · Received May 28, 2014

    Report

    Report Number
    3852940
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    December 3, 2013
    Report Date
    May 28, 2014
    Manufacturer
    ARGON MEDICAL CORP.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO WORK ONCE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314219 ARTERIAL CATHETER KIT GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY ARGON MEDICAL CORP. 498110 99768048

    Patients

    Seq Age Sex Outcome Treatment
    1 *