BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3823870 · Received February 21, 2014

    Report

    Report Number
    1721504-2014-00025
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A RETURNED DEVICE FROM THE SAME LOT WAS EXAMINED VISUALLY AND PRESSURE TESTED. THE COMPLAINT IS NOT CONFIRMED, NO LEAKS WERE FOUND. THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AIR ENTERED THE SYSTEM FROM A BONDED CONNECTION OF THE KIT DURING A CORONARY ANGIOGRAPHIC PROCEDURE. NO AIR WAS INJECTED. THE DEVICE WAS REPLACED AND THE PRODUCE COMPLETED WITHOUT FURTHER COMPLICATIONS. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109731 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H538174

    Patients

    Seq Age Sex Outcome Treatment
    1