BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2062459 · Received March 18, 2011

    Report

    Report Number
    1721504-2011-00103
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVAL. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE SUSPECT DEVICE. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. EVAL, METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AFTER PRESSURIZING THE SALINE BAG TO 250 - 300 MMHG, THE CUSTOMER REPORTED THAT THE ROLLER CLAMP WOULD NOT CLOSE OFF ALL THE WAY, THE ROLLER WOULD POP OUT, AND THAT THE ROLLER WAS DIFFICULT TO MANIPULATE. THE CUSTOMER REPORTED THAT THIS HAPPENED FOUR TIMES. NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER WILL NOT BE RETURNING ANY DEVICES FOR EVAL. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FOUR REPORTS FOR THIS EVENT: 1721504-2011-00102, 1721504-2011-00104, 1721504-2011-00105.

    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 SALINE