BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHO CATH LEFT

    MDR report key: 1211044 · Received October 24, 2008

    Report

    Report Number
    2936999-2008-00488
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE ENDOBRONCHIAL TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBE WAS CHECKED AS PER INFLATION OF CUFF. THE PATIENT WAS INTUBATED AND A SOUND WAS HEARD WHICH SOUNDED LIKE A CUFF LEAK. THE PATIENT WAS EXTUBATED AND UPON INSPECTION NO CUFF PROBLEM, SO IMMERSED IN WATER AND FOUND LEAK AT PILOT VALVE. IT WAS REPORTED THAT THERE WERE NO ILL-EFFECTS TO THE PATIENT, AND PATIENT STATUS REPORTED AS FINE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHO CATH LEFT ENDOBRONCHIAL TUBE CBI COVIDIEN/FORMERLY TYCO HEALTHCARE 2008044298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention