BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM CONVENIENCE KIT

    MDR report key: 744213 · Received June 29, 2005

    Report

    Report Number
    1721504-2005-00050
    Event Type
    Malfunction
    Date Received
    June 29, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 2, 2005
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO MERIT MEDICAL SYSTEMS. THEREFORE, AN INVESTIGATION COULD NOT BE CONDUCTED. THIS EVENT IS ATTRIBUTABLE TO USER ERROR. THE FACILITY STATES THAT THEY WERE DISCONNECTING PROXIMAL TO THE CHECK VALVES LEAVING THE CONTAMINATED PART IN POSITION. REUSING THIS PART ON THE NEXT PATIENT CREATES CROSS-CONTAMINATION RISK. CORRECTIVE ACTION TAKEN AT THIS TIME IS TO DISCONTINUE USE OF CURRENT KITS AND WORK WITH MERIT'S SALES REPRESENTATIVE TO CREATE A NEW KIT WHERE THE CONNECTIONS ARE BONDED, THUS PREVENTING THE POTENTIAL FOR CROSS-CONTAMINATION. THE CONTAMINATION WAS TREATED EFFECTIVELY AND IN AN APPROPRIATE MANNER BY THE HOSPITAL. THERE WERE NO CONSEQUENCES FOR THE PATIENT OR STAFF.

    Description of Event or Problem · 1

    TWICE DURING A CT PROCEDURE, WHILE USING KIT K08-00861L IN COMBINATION WITH KIT K08-01154, CROSS-CONTAMINATION OCCURRED. KIT K05-00861L CONTAINS TWO CHECK VALVES IN SERIES TO PREVENT BACKFLOW CONTAMINATION. WHEN DETACHING THE K08-00861L FROM THE K08-000154, THE USER DISCONNECTED PROXIMAL TO THE CHECK VALVES LEAVING A CONTAMINATED PART IN POSITION FOR THE NEXT PATIENT. THE PATIENT INVOLVED WAS A HIGH-RISK HEPATITIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM CONVENIENCE KIT LARGE BORE TUBING (COMPONENT OF KIT) BYX MERIT MEDICAL SYSTEMS, INC. NA C384634

    Patients

    Seq Age Sex Outcome Treatment
    1