BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1791274 · Received August 6, 2010

    Report

    Report Number
    1721504-2010-00227
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    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: THE SUSPECT DEVICE WAS RETURNED FOR EVAL. THE EVAL HAS NOT BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM. THIS HAPPENED TWICE. INJECTOR SETTINGS: FLOW: 10ML/S, VOLUME: 30ML, PRESSURE LIMIT: 1000 PSI. NO HARM OR INJURY WAS REPORTED THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT - 1721504-2010-00226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F714639

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| 5F PIGTAIL CATHETER