BEUDAMED
    FDA Adverse Event Death Summary report: N

    8.0 MM HI-LO

    MDR report key: 1201782 · Received October 17, 2008

    Report

    Report Number
    2936999-2008-00461
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 19, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NO. IS UNK. THE TUBE WAS DISCARDED, AND THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE LOT NUMBER IS OBTAINED, THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IT IS NOT KNOWN IF CUFF INFLATION PRE-TESTING WAS PERFORMED ON THE TUBE AS SPECIFIED IN THE MFR'S DIRECTIONS FOR USE. IF NEW OR SIGNIFICANT INFO IS GAINED AT THE CONCLUSION OF THE COMPLAINT INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS INTUBATED IN THE EMERGENCY DEPARTMENT, AND TRANSFERRED TO THE INTENSIVE CARE UNIT. IN THE INTENSIVE CARE UNIT, THE ENDOTRACHEAL TUBE WAS NOTED TO BE LEAKING AND THE PT WAS EXTUBATED, AND ANOTHER ENDOTRACHEAL TUBE WAS PUT IN PLACE. THE ENDOTRACHEAL TUBE WAS NOT KEPT, AND THE LOT NUMBER IS NOT KNOWN. IT WAS REPORTED THAT SINCE THEN, THE PT HAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0 MM HI-LO ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R