BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1791297 · Received August 6, 2010

    Report

    Report Number
    1721504-2010-00233
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 5, 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 EVAL/INVESTIGATION HAS NOT BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. COMPLAINT DATA BASE 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: OTHER, A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR OF THE H3RRC BROKE DURING AN ANGIOGRAPHIC PROCEDURE. INJECTOR SETTINGS: FLOW: 8ML/S, VOLUME: 12ML, PRESSURE LIMIT: 1000 PSI. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE SECOND DEFECTIVE DEVICE. THE CUSTOMER RETURNED ONE DEVICE FOR EVAL/INVESTIGATION. THEREFORE, THIS SINGLE MDR REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F740830

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MARKV MEDRAD| 4F PIGTAIL CATHETER| CONTRAST MEDIA