BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 2002547 · Received January 28, 2011

    Report

    Report Number
    1721504-2011-00031
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K932251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE EVALUATION HAS NOT BEEN COMPLETED. THE CUSTOMER RETURNED ONE USED AND FIVE NEW DEVICES FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING AN AORTIC ANGIOGRAM AT LESS THAN 1200 PSI. NO PATIENT HARM OR INJURY WAS REPORTED. THE CUSTOMER STATED THIS HAPPENED ON SEVERAL OCCASIONS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THE CUSTOMER IS EXPECTED TO RETURN ONE USED DEVICE FOR EVALUATION. THEREFORE, THIS SINGLE FDA 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F693809

    Patients

    Seq Age Sex Outcome Treatment
    1 PIGTAIL CATHETER| PRESSURE SYRINGE| CONTRAST MEDIA