BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 2050091 · Received April 4, 2011

    Report

    Report Number
    2183502-2011-00128
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 30, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD AND RELATED DOCUMENTS DID NOT SHOW ANY RELATED MANUFACTURING ISSUES. INSPECTION AND TESTING INDICATED THAT THE DEVICE MET WITH REQUIREMENTS PRIOR TO RELEASE. THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. INVESTIGATION DETERMINED THAT THE RETURNED SAMPLE MET MANUFACTURING AND DIMENSIONAL REQUIREMENTS FOR THIS PRODUCT. THE DEVICE PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN 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 CUFFED PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 1760201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK