BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1943985 · Received December 3, 2010

    Report

    Report Number
    1721504-2010-00406
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL/INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORD AND THE COMPLAINT DATA BASE COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL/INVESTIGATION IS COMPLETED. EVAL METHOD: WITHOUT THE LOT NUMBER A DEVICE HISTORY RECORD AND COMPLAINT DATA BASE REVIEW COULD NOT BE PERFORMED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY ARE HAVING DIFFICULTY CLEARING THE LINE OF AIR BUBBLES. NO REPORT OF AIR INJECTED INTO THE PT. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED 20 DEFECTIVE BUT COULD NOT PROVIDE ANY SPECIFIC INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. CUSTOMER IS NOT EXPECTED TO RETURN ANY DEVICES FOR EVAL/INVESTIGATION. NO LOT NUMBER PROVIDED. THEREFORE THIS SINGLE FORM FDA 3500A REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA