BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2002557 · Received January 28, 2011

    Report

    Report Number
    1721504-2011-00034
    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
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD AND COMPLAINT DATA BASE REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: METHOD - THE LOT NUMBER WAS NOT PROVIDED, UNABLE TO REVIEW THE DEVICE HISTORY RECORD AND THE COMPLAINT DATA BASE. CONCLUSIONS - A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY ARE HAVING MICRO BUBBLES AND BROKEN CONNECTIONS WITH THE KIT. THE CUSTOMER BELIEVES THE SYRINGE IS NOT MAKING A TIGHT CONNECTION OR IS SOMEHOW ALLOWING AIR INTO THE TUBING SYSTEM. THIS IS HAPPENING WHILE PREPARING THE DEVICE FOR USE. THE CUSTOMER IS NOT EXPECTED TO RETURN THE DEVICE FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. NO HARM OR INJURY WAS REPORTED.

    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