BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 835476 · Received April 3, 2007

    Report

    Report Number
    1217052-2007-00034
    Event Type
    Injury
    Date Received
    April 3, 2007
    Report Date
    March 1, 2007
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTERNATIONA LTD., HAS BEEN NOTIFIED OF SEVERAL EVENTS OF USER ALLEGING THE TUBE WAS IN PLACE AND THEN THE FLANGE SEPARATED FROM THE TUBE. THE TUBES WERE REPLACED. NO ADVERSE OUTCOME REPORTED. REPORTED TO SMITHS MEDICAL INTERNATIONA LTD. BY PHARMACY. THE USER ALLEGES SEVERAL EVENTS, HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * 695406

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention