BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1942033 · Received November 9, 2010

    Report

    Report Number
    1721504-2010-00369
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE CUSTOMER IS NOT RETURNING THE SUSPECT DEVICE FOR EVAL/INVESTIGATION. COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE REVIEW FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW REVEALED THAT THE HIGH PRESSURE STOPCOCK USED IN THIS KIT WAS BUILT BEFORE IMPLEMENTATION OF CORRECTIVE ACTIONS FOR THE ROTATOR COLLAR TO ROTATOR HOUSING BOND. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MFG BONDING PROCESS. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. EVAL, METHOD: DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT HAS NOT PROVIDED ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENT. THE CUSTOMER IS NOT GOING TO RETURN ANY DEVICES RELATING TO THIS EVENT. 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. H113066

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA