BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE 5MM X 33CM, DISP FIXED

    MDR report key: 7245415 · Received February 6, 2018

    Report

    Report Number
    1423537-2018-00151
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 8, 2018
    Report Date
    June 28, 2018
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    UDI-DI
    10630140169694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE UNABLE TO CONFIRM THE ISSUE REPORTED. HOWEVER, CARDINAL HEALTH HAS BECOME AWARE OF AN ISSUE IN WHICH THE HYDROLINE AND PULSE WAVE TRUMPET VALVES MAY NOT CLOSE PROPERLY, WHICH COULD CAUSE CONTINUOUS SUCTION. THERE IS A REMOTE POSSIBILITY THAT INABILITY TO CONTROL SUCTION DURING A PROCEDURE MAY RESULT IN LOSS OF CARBON DIOXIDE IN THE ABDOMEN, REDUCED VISIBILITY OF THE SURGICAL SITE AND POTENTIAL INJURY TO ORGANS AND BODY TISSUE. CARDINAL HEALTH HAS ISSUED A VOLUNTARY RECALL THAT WAS INITIATED ON JUNE 11TH 2018.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. TWO LOT NUMBERS (031751 & 041720) WERE INVOLVED IN THIS REPORTED INCIDENT. THE FIRST LOT NUMBER 031751 WAS MANUFACTURED ON 3/23/2017 AND THE SECOND LOT NUMBER 041720 WAS MANUFACTURED ON 6/29/2017. THE DEVICE HISTORY RECORDS(DHRS) FOR BOTH LOT NUMBERS WERE REVIEWED FOR CONFORMANCE TO THE CARDINAL HEALTH SPECIFICATIONS. THE PRODUCTS ARE TESTED 100% FOR LEAKS. SPECIFICALLY THE ¿RED BUTTON¿ IS DEPRESSED, OPENED AND CLOSED SEVERAL TIMES DURING THE TEST FOR LEAKS, AND VISUAL INTEGRITY APPEARS TO BE IN CONFORMANCE. THE PRODUCT DHRS CONFORMS TO CARDINAL HEALTH SPECIFICATIONS. TESTING WERE PERFORMED PRIOR TO FINAL PACKAGING AND STERILIZATION AND MET REQUIREMENTS. IF THE PRODUCTS ARE RETURNED IN THE FUTURE, THEY WILL BE PHYSICALLY EVALUATED AND A FOLLOW-UP REPORT FILED

    Description of Event or Problem · 1

    THE SUCTION TUBE WITH TRUMPET WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY. THE RED BUTTON OF THE TRUMPET VALVE DID NOT WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89387 PROBE 5MM X 33CM, DISP FIXED CATHETER, IRRIGATION GBX CARDINAL HEALTH ASU1200 031751 & 041720 10630140169694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention