BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY TUBE

    MDR report key: 1041040 · Received March 31, 2008

    Report

    Report Number
    1217052-2008-00058
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    SMITHS HEALTHCARE MFG S.A. DE C.V., AVE
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL HAS INFORMED US OF AN EVENT THAT THERE WAS LEAKAGE THROUGH THE CUFF. IT IS NOT KNOWN HOW LONG THE TUBE WAS IN PLACE. THE TUBE WAS REPLACED. THE UNIT WAS PRETESTED PER THE INSTRUCTIONS FOR USE. NO ADVERSE OUTCOME. EVENT OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH SMITHS HEALTHCARE MFG S.A. DE C.V., AVE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * VENTILATOR