BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1854440 · Received September 3, 2010

    Report

    Report Number
    1721504-2010-00263
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE CAUSING CONTRAST AND BLOOD TO SPRAY. THIS HAPPENED ON THREE (3) ADDITIONAL CASES. THE CLINIC DISPOSED OF THE DEVICES. CUSTOMER BELIEVES IT IS A PROBLEM WITH THE CONNECTION TO THE CATHETER AND NOT THE ROTATOR SEPARATING. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THIS HAPPENED ON THREE ADDITIONAL CASES. THE CUSTOMER HAS NOT PROVIDED ANY INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THE CUSTOMER DISPOSED OF ALL DEVICES. THE CUSTOMER WILL RETURN ONE SINGLE UNUSED DEVICE FOR EVAL. THEREFORE, THIS SINGLE REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR, PVC CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. H105474

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA