BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLUE LINE CUFFED ORAL/NASAL ENDOTRACHEAL TUBE

    MDR report key: 933015 · Received October 17, 2007

    Report

    Report Number
    1217052-2007-00127
    Event Type
    Death
    Date Received
    October 17, 2007
    Date of Event
    June 18, 2007
    Report Date
    September 21, 2007
    Manufacturer
    SMITHS HEALTHCARE MFG S.A. C.V.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INT'L LTD., HAS BEEN NOTIFIED OF AN EVENT THAT THE USER ALLEGES THAT FOLLOWING INTUBATION OF THE TUBE THE CUFF OF THE TRACHEAL TUBE COULD NOT BE INFLATED. THE PT DIED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE CUFFED ORAL/NASAL ENDOTRACHEAL TUBE 73 BTR - TUBE, TRACHEAL WITH/WITHOUT CONNECTOR BTR SMITHS HEALTHCARE MFG S.A. C.V. * 901055

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death