BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID ADMINISTRATION SET

    MDR report key: 3101625 · Received May 3, 2013

    Report

    Report Number
    1721504-2013-00102
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K915678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A COILING PROCEDURE AIR BUBBLES WERE SEEN IN THE FLUID ADMINISTRATION TUBING. THE USER COULD NOT IDENTIFY WHERE THE BUBBLES WERE COMING FROM. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194975 FLUID ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA MERIT MEDICAL SYSTEMS, INC. H446977

    Patients

    Seq Age Sex Outcome Treatment
    1