BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 857093 · Received May 24, 2007

    Report

    Report Number
    1217052-2007-00055
    Event Type
    Injury
    Date Received
    May 24, 2007
    Report Date
    April 26, 2007
    Manufacturer
    MFG FOR SMITHS MED BY: SMITHS MED INTERNATIONAL LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTERNATIONAL LTD., HAS BEEN NOTIFIED OF AN EVENT OF CUFF LEAKAGE AFTER 19 DAYS IN USE RESULTING IN EMERGENT TUBE REPLACEMENT. EVENT OCCURRED AT HOME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE ULTRA TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH MFG FOR SMITHS MED BY: SMITHS MED INTERNATIONAL LTD. * 499258

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention