BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1791302 · Received August 6, 2010

    Report

    Report Number
    1721504-2010-00235
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE(S) WILL NOT BE RETURNED FOR EVAL/INVESTIGATION. THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY ARE GETTING AIR IN THE TUBING LINE. THERE WAS NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED FIVE (5) DEFECTIVE DEVICES, BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADD¿L DEFECTIVE DEVICES. THE CUSTOMER WILL NOT BE RETURNING ANY DEVICES FOR EVAL/INVESTIGATION, NOR DID THEY PROVIDE ANY LOT NUMBER(S). THEREFORE, THIS SINGLE MDR REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA