BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1963722 · Received December 22, 2010

    Report

    Report Number
    1721504-2010-00451
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 3, 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: TWO USED SUSPECT DEVICES WERE RETURNED FOR EVAL. THE COMPLAINT WAS CONFIRMED. THE ROTATOR SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MFG BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THIS LOT WAS 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 DATA BASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE. PRESSURE LIMIT 800 PSI, FLOW 2, VOLUME 4. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE BUT HAS NOT PROVIDED ADD'L DETAILS AND CLINICAL INFO FOR THE ADD'L EVENT. THEREFORE, THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F699819

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA