BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC, CLEAR, CONTRAST INJECTION TUBING

    MDR report key: 2093243 · Received April 14, 2011

    Report

    Report Number
    1721504-2011-00136
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION AS TO IF THIS WAS THE INITIAL USE OF THE DEVICE. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THIS LOT WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. THE CUSTOMER REPORTED THAT THIS OCCURRED FOUR TIMES. INJECTOR SETTINGS: 10 ML/SEC FOR A TOTAL OF 30 ML AT 600 PSI. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FOUR REPORTS FOR THIS COMPLAINT: 1721504-2011-00137, 1721504-2011-00138, 1721504-2011-00139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVC, CLEAR, CONTRAST INJECTION TUBING DISPLAY, CATHODE RAY-TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F731037

    Patients

    Seq Age Sex Outcome Treatment
    1 4FR PIGTAIL CATHETER