BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 835466 · Received April 2, 2007

    Report

    Report Number
    1217052-2007-00024
    Event Type
    Injury
    Date Received
    April 2, 2007
    Report Date
    March 4, 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 INTERNATION LTD., HAS BEEN NOTIFIED OF ONE EVENT OF USER ALLEGING THE TUBE WAS IN PLACE FOR FIVE DAYS AND BROKE INTO TWO PARTS. THE TUBE WAS REPLACED. NO ADVERSE OUTCOME REPORTED. REPORTED TO SMITHS MEDICAL INTERNATIONAL LTD. BYPHARMACY.

    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