BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3050221 · Received April 5, 2013

    Report

    Report Number
    1125782-2013-00009
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND TWO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONFIRMED, THE VALVE BODY OF THE CATHETER HAD DETACHED FROM THE CATHETER HUB. THE ROOT CAUSE IS ATTRIBUTED TO THE ASSEMBLY PROCESS. CORRECTIVE ACTIONS WERE IMPLEMENTED IN DECEMBER 2012 TO CORRECT THIS ISSUE. THIS DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A PARACENTESIS PROCEDURE THE VALVE BODY OF THE DRAINAGE CATHETER INCLUDED IN THE KIT DETACHED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141718 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. T412415

    Patients

    Seq Age Sex Outcome Treatment
    1