BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1932210 · Received December 14, 2010

    Report

    Report Number
    1721504-2010-00426
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL - THE DEVICE HAS NOT BEEN RETURNED FOR EVAL/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. EVAL - METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE TUBING ATTACHED TO THE PUMP DISCONNECTED UNDER HIGH PRESSURE CAUSING SPRAY IN THE LAB. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT DISPLAY, CATHODE-RAY-TUBE, MEDICAL DQO MERIT MEDICAL SYSTEMS, INC. F647375

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA