BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 1250536 · Received September 25, 2008

    Report

    Report Number
    9610530-2008-00043
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 10, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTERNATIONAL LTD., HAS BEEN NOTIFIED OF AN EVENT THAT AIR LEAKAGE THROUGH THE PILOT BALLOON AFTER TUBE WAS IN USE FOR TWO WEEKS. UNIT WAS PRETESTED PER INSTRUCTIONS FOR USE. NO ADVERSE OUTCOME. EVENT OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE TRACHEOSTOMY TUBE 73 BTO - TRACHEOSTOMY TUBE, SINGLE-USE BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *