BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2093236 · Received April 14, 2011

    Report

    Report Number
    1721504-2011-00142
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 18, 2011
    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

    TWO USED SUSPECT DEVICES WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION AS TO IF THIS WAS THE INITIAL USE OF THE DEVICE. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THIS SUBASSEMBLY WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE STOPCOCK BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THREE DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. H103526

    Patients

    Seq Age Sex Outcome Treatment
    1