BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE CUFFED ORA/NASAL ENDOTRACHEAL TUBE

    MDR report key: 1012128 · Received February 20, 2008

    Report

    Report Number
    1217052-2008-00016
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 21, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE HAS INFORMED US OF AN EVENT OF LEAKAGE THROUGH THE CUFF AFTER IN USE FOR THREE OR FOUR DAYS. THE PRODUCT WAS TESTED BEFORE USE AND ORALLY INSERTED IN THE PT. AFTER FOUR DAYS THE USER NOTICED THE PILOT BALLOON DEFLATED AND INFUSED AIR. AFTERWARD AIR WAS INFUSED REPEATEDLY AS THE PILOT BALLOON DEFLATED. ON DAY SEVEN THE TUBE WAS REMOVED AND ANOTHER ONE WAS USED. NO ADVERSE OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * VENTILATOR