BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MANIFOLD WITH INTEGRATED STOPCOCK

    MDR report key: 1963554 · Received December 20, 2010

    Report

    Report Number
    1721504-2010-00439
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K913161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CUSTOMER REPORTED TWO NEW DEVICES FROM THE SAME LOT AS THE REPORTED DEFECTIVE DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A REVIEW OF THE COMPLAINT DATABASE FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE RETURNED DEVICES WERE EXAMINED VISUALLY, INSPECTED, AND PRESSURE TESTED. THE DEVICES MET ALL SPECS. CUSTOMER COMPLAINT NOT CONFIRMED. UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. NO CONCLUSION CAN BE DRAWN. THE COMPLAINT DATABASE WILL BE MONITORED FOR THIS TYPE OF REPORTED FAILURE. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 'AIR WENT INSIDE DURING OPERATION'. THE PT WAS REPORTED TO BE IN GOOD CONDITION. THE CUSTOMER WAS NOT WILLING TO SHARE ANY ADD'L INFO OR CLINICAL DETAILS OF THE EVENT. NO HARM OR INJURY REPORTED. THE CUSTOMER ALSO REPORTED FOUR DEFECTIVE DEVICES, BUT WOULD NOT PROVIDE ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT MANIFOLD WITH INTEGRATED STOPCOCK ADAPTER, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS, INC. H100921

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST