BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM KIT, CT-SET

    MDR report key: 959985 · Received May 2, 2007

    Report

    Report Number
    9616662-2007-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 20, 2007
    Manufacturer
    MERIT MEDICAL IRELAND, LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIES OF INJECTION AND ASPIRATION MANIPULATIONS WERE PERFORMED WITHIN A CLOSED AND OPEN SYSTEM ON BOTH DEVICES. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO SIGNIFICANT ANOMALIES WERE IDENTIFIED. RESULTS: THE USED UNIT WAS FOUND TO HAVE A LEAK AT A VALVE TO TUBING BOND. THE UNUSED DEVICE SHOWED NO SIGNS OF LEAKAGE WHEN TESTED UNDER THE SAME CONDITIONS. CONCLUSION: AN EZEM SYRINGE WHICH WAS FURTHER CONNECTED TO AN EZEM PUMP WAS BEING USED IN THE CLINICAL SETTING IN CONJUNCTION WITH THIS DEVICE. THE HIGHER PRESSURES EXERTED BY THIS SYRINGE AND PUMP MAY HAVE RESULTED IN THE BOND FAILING. THERE IS A PROJECT IN PROGRESS TO IMPLEMENT NEW VALVES AND TUBING THAT ARE CAPABLE OF WITHSTANDING HIGHER PRESSURES. THE NEW CONFIGURATION WILL INCLUDE A BOND WHICH IS ALSO DESIGNED TO WITHSTAND HIGER PRESSURES. THE EXPECTED COMPLETION DATE IS MAY 2007. THIS INCIDENT WAS REPORTED IN MDR #9616662-2007-00001 (DEVICE2). DURING A CONVERSATION WITH JAN DAVIS (FDA), IT WAS RECOMMENDED A SEPARATE REPORT BE FILED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING A CONTRAST INJECTION PROCEDURE THERE WERE 3 FAILURES ON 2 PATIENTS WITH CT KITS. IT WAS REPORTED THAT CONTAST WAS SPURTING OUT FROM ONE OF THE VALVES OR FROM THE TUBING BETWEEN THE VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM KIT, CT-SET FLUID ADMINISTRATION SYSTEM FPA MERIT MEDICAL IRELAND, LTD. NA W496873

    Patients

    Seq Age Sex Outcome Treatment
    1 CT TRASFER LINE (K08-00801)| PRESSURE INJECTOR (EZEM FASTLOAD SYRINGE)