BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1934742 · Received November 29, 2010

    Report

    Report Number
    1721504-2010-00395
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: TWO USED DEVICES WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A REVIEW OF THE COMPLAINT DATA BASE DID NOT REVEAL ANY SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICES WERE EXAMINED VISUALLY AND CHECKED WITH CALIBRATED GAUGES. THE LEAD THREAD ON EACH LUER HAS SLIGHT DAMAGE. NO DIMENSIONAL ANOMALIES WERE NOTED DURING THE INSPECTION. THE POWER INJECTOR SYRINGE WAS NOT RETURNED TO EVALUATE. UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. NO CONCLUSION CAN BE MADE. COMPLAINT DATA BASE WILL CONTINUE TO BE MONITORED FOR THIS TYPE OF FAILURE. EVALUATION METHOD: A REVIEW OF THE DEVICE HISTORY RECORD, THE COMPLAINT DATA BASE WAS REVIEWED. RESULTS: UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    TWO HIGH PRESSURE TUBING LINES DISCONNECTED FROM THE INJECTOR SYRINGE DURING INJECTION. CONTRAST SPRAYED. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES AND RETURNED TWO DEVICES. ADD'L INFO FOR THE REPORTED TWO EVENTS WAS NOT PROVIDED. THIS IS ONE OF TWO FORM FDA 3500A REPORTS FOR THIS COMPLAINT, 1721504-2010-00396.

    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. H135847

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA