BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 1871218 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00446
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE CUFF WAS ASYMMETRIC AND AS A RESULT THE PT'S TRACHEA WAS NOT FULLY BLOCKED BY THE CUFF. THEY REPORT THAT THIS ALLOWED SECRETIONS AND FEEDS TO ENTER THE PT'S AIRWAY. THE AIRWAY WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE JOH-TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention