BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 769861 · Received September 25, 2006

    Report

    Report Number
    1217052-2006-00078
    Event Type
    Injury
    Date Received
    September 25, 2006
    Date of Event
    August 24, 2006
    Report Date
    August 25, 2006
    Manufacturer
    SMITHS HEALTHCARE MFG S.A. DE C.V.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTERNATIONAL LTD., HAS BEEN NOTIFIED OF ONE EVENT OF THE PT TAKEN CARE OF AT HOME AND VISITIS PEDIATRIC OUTPATIENT ONCE A WEEK TO HAVE HER TRACH TUBE REPLACED. THE PT HAD THE TUBE REPLACED AND THE NEXT NIGHT HER MOTHER NOTICED SOMETHING WRONG WITH THE PT AND FOUND THE FLANGE OF THE TUBE HAD COME OFF THE TUBE. THE TUBE REMAINED ON THE STOMA WITHOUT FALLING DOWN INTO TRACHEA. THE MOTHER PULLED THE REMAINING TUBE OUT OF THE STOMA AND INSERTED A 100/506/035 TUBE. NO ADVERSE OUTCOME TO PT. EVENT OCCURRED AT MED CTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH SMITHS HEALTHCARE MFG S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention BRONCHOSCOPE