BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBE

    MDR report key: 1893828 · Received November 1, 2010

    Report

    Report Number
    2183502-2010-00506
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 30, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN REPORTED AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK