BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBE

    MDR report key: 1882302 · Received October 21, 2010

    Report

    Report Number
    2183502-2010-00479
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 20, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION REVEALED THE PRESENCE OF DAMAGE TO THE CUFF. AN ABRADED AREA 4.5 MM IN SIZE WAS NOTED ON THE UPPER 2/3 OF THE CUFF FROM THE DISTAL TIP AND ON THE END USER'S RIGHT SIDE WHEN IN-SITU. UPON EXAMINATION VIA MAGNIFICATION, THE ABRADED WAS COMPRISED OF SCORE MARKS THAT MEASURED APPROX 1.0 MM IN LENGTH. DURING PERFORMANCE TESTING, THE DEVICE WAS NOTED TO LEAK FROM THE LOCATION OF THE DAMAGE. IT SHOULD BE NOTED THAT THE PRODUCT DID NOT BECOME DEFLATED UNTIL GREATER THAN ONE HOUR POST PLACEMENT AND THE INITIAL REPORTER STATED THAT THE DEVICE WAS LEAKED TESTED PRIOR TO INSERTION. OUR QUALITY PERSONNEL DETERMINED THE DAMAGE WAS CAUSED DURING CUSTOMER USE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER GREATER THAN 1 HOUR IN SITU. REPLACEMENT WAS REQUIRED. THE REPORTER STATED THAT A VENTILATOR ALARM ALERTED THEM TO A LOW VOLUME CONDITION, A TRACH CHANGE SILENCED THE ALARM. THE TRACH WAS TESTED PRIOR TO USE AND DID NOT LEAK BEFORE INSERTION. NO FURTHER INCIDENT RELATED MEDICAL SEQUELAE 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 1796649

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention