BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1930028 · Received November 19, 2010

    Report

    Report Number
    1721504-2010-00391
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: TWO USED DEVICES WERE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND THE SIMILAR COMPLAINT FOR THIS LOT NUMBER. THE DEVICES WERE VISUALLY EXAMINED AND THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THE SUB-ASSEMBLIES USED IN THIS LOT WERE BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. 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. NO HARM INJURY WAS REPORTED. CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT HAS NOT PROVIDED ADDITIONAL INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENT. THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. F765238

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA