BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC

    MDR report key: 2114235 · Received May 24, 2011

    Report

    Report Number
    2114235
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 24, 2011
    Manufacturer
    NAVILYST MEDICAL INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS NOTED THAT THE CONTRAST CONTROLLER OUT OF NAMIC KIT (SEALED MANUFACTURED ONE TIME USE DEVICE) WHICH HAS A GRADUATED CHAMBER AND IS SUPPOSED TO HAVE A BALL THAT FLOATS IN THAT CHAMBER TO PREVENT ASPIRATION OF AIR INTO THE CONTRAST SYRINGE WAS NOT IN PLACE. THE ENTIRE UNIT WAS REMOVED FROM THE FIELD AND A NEW ONE, THAT WAS CLOSELY INSPECTED AND COMPLETE WAS PLACED INTO SERVICE. NO APPARENT HARM TO PATIENT DURING OR NOTED AFTER PROCEDURE. PATIENT REMAINED PAIN FREE AND VITAL SIGNS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC NAMIC CONVENIENCE KIT DQO NAVILYST MEDICAL INC * 4101398

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR