BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE CUFFED ORAL/NASAL ENDOTRACHEAL TUBE

    MDR report key: 1140323 · Received June 6, 2008

    Report

    Report Number
    1217052-2008-00083
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MFG FOR SMITHS MED BY: SMITHS HEALTHCARE MFG 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

    SMITHS MEDICAL HAS INFORMED US OF AN EVENT OF LEAKAGE THROUGH THE PILOT BALLOON AFTER IN USE FOR SIX DAYS. NO ADVERSE OUTCOME. UNIT WAS PRETESTED. EVENT OCCURRED AT HOSP.

    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 MFG FOR SMITHS MED BY: SMITHS HEALTHCARE MFG S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * VENTILATOR