BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUGAN CO. LTD. MS2602A - CUSTOM ANGIO KIT

    MDR report key: 898707 · Received October 25, 2006

    Report

    Report Number
    1721504-2006-00032
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Date of Event
    August 28, 2006
    Report Date
    September 25, 2006
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED FOR EVAL. THE DEVICE WAS VISUALLY EXAMINED PRIOR TO TESTING. THE DEVICE WAS TESTED FOR LEAK UNDER PRESSURE AND UNDER VACUUM. HANDLE TORQUE TESTING WAS ALSO PERFORMED. THE PRESSURE LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH COLORED WATER AND THEN PRESSURIZING THE DEVICE BEYOND THE RATED SPEC FOR 30 SECONDS. THE DEVICE PASSED THE LEAK SPEC. VACUUM TESTING USING A SYRINGE WAS PERFORMED MULTIPLE TIMES WITH THE HANDLES IN DIFFERENT POSITIONS TO TEST ALL PORTS. AT NO TIME WAS THERE ANY EVIDENCE OF BUBBLES OR AIR IN THE MANIFOLD. THE SUSPECT DEVICE WAS ALSO TESTED FOR THE TORQUE FORCE REQUIRED TO TURN EACH HANDLE. ALL FOUR OF THE HANDLES PASSED THE TORQUE SPEC. THE FAILURE COULD NOT BE REPLICATED. THEREFORE, NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT AIR CAME FROM THE CONNECTION ON THE SECOND PORT OF THE MANIFOLD. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING THE PROCEDURE WITH NO HARM OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUGAN CO. LTD. MS2602A - CUSTOM ANGIO KIT CONVENIENCE KIT DQO MERIT MEDICAL SYSTEMS, INC. NA F441524

    Patients

    Seq Age Sex Outcome Treatment
    1