BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID ADMINISTRATION SET

    MDR report key: 2222952 · Received August 10, 2011

    Report

    Report Number
    1721504-2011-00240
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K915678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE CUSTOMER ALSO DID NOT PROVIDE A LOT NUMBER. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLAMP DOES NOT STOP THE FLOW OF FLUID. THE CUSTOMER REPORTED THAT THE CLAMPS FAIL INTERMITTENTLY. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED FOUR ADDITIONAL TIMES WITH FLUID ADMINISTRATION SETS IN CUSTOM KIT CONFIGURATIONS. NO FURTHER INFO OR CLINICAL DETAILS WERE PROVIDED BY THE CUSTOMER FOR THE ADD'L EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1