BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRD FLEX ADVAN, BIG W/ M EDISTOP,1L 6MM, 180 CM

    MDR report key: 3191446 · Received June 26, 2013

    Report

    Report Number
    1423537-2013-00028
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RECEIVED AND DETAILED INVESTIGATION ON THE REPORTED CONCERN WAS CONDUCTED. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD FOR THE REFERENCED LOT NUMBER WAS COMPLETED. NO NON- CONFORMANCE WITH REGARD TO ¿SUCTION FAILURE¿ WAS DOCUMENTED DURING THE MANUFACTURING OF THIS BATCH OR IS PRESENT IN CURRENT PRODUCTION. THE INVESTIGATION DETERMINED THAT ALL PRODUCTS WERE MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE TO OUR ESTABLISHED SPECIFICATION FOR QUALITY AND EFFICACY. A DETAILED INVESTIGATION WAS CONDUCTED ON THE SAMPLE RECEIVED. THE SAMPLE WAS SUBJECTED TO A VISUAL INSPECTION AND INTERMITTENT DIP TEST. THE VISUAL INSPECTION REVEALED NO DEFECTS AND THE INTERMITTENT DIP TEST AT 700MMHG WAS PERFORMED ON THE LINER AND IT FUNCTIONED AS DESIGNED. BASED ON THE FACT THAT THE SAMPLE RECEIVED FUNCTIONED AS DESIGNED AND WE WERE NOT ABLE TO DUPLICATE THE CONCERN, A ROOT CAUSE CANNOT BE IDENTIFIED AND A CORRECTIVE AND PREVENTIVE ACTION CANNOT BE INITIATED. WE WILL CONTINUE TO MONITOR TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    NO ASPIRATION DURING PROCEDURE. PRACTITIONER CHECKED ASPIRATION SYSTEM BEFORE USE AND IT WAS FUNCTIONING. HOWEVER, SUCTION FAILED DURING ADENOIDECTOMY ON A (B)(6) GIRL. AS A RESULT, THE PATIENT TURNED BLUE UNTIL SUCTION WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291302 CRD FLEX ADVAN, BIG W/ M EDISTOP,1L 6MM, 180 CM SUCTION LINER GCX CARDINAL HEALTH 65653916 13C09

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention