BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL BIVONA TUBES ADULT HYPERFLEX TTS

    MDR report key: 8488775 · Received April 5, 2019

    Report

    Report Number
    3012307300-2019-01779
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 13, 2019
    Report Date
    September 24, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312013825
    PMA / PMN Number
    K081440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE BIVONA TRACHEOSTOMY TUBE WAS RECEIVED IN USED CONDITION. THE TRACHEOSTOMY TUBE WAS RETURNED FOR A LOSS OF VENTILATION DUE TO A CUFF LEAK. THE RETURNED DEVICE WAS LEAK TESTED WITH 200 CC OF AIR. THE CUFF WAS UNABLE TO FULLY INFLATE AND IMMEDIATELY DEFLATED AS AIR ESCAPED FROM A SMALL HOLE/ SCRATCH IN THE CUFF. UPON VISUAL INSPECTION OF THE CUFF, IT WAS NOTED THAT THERE ARE TWO SCRATCHED AREAS NEXT TO THE SMALL HOLE ON THE CUFF, PERHAPS CAUSED BY THE DEVICE COMING INTO CONTACT WITH SOMETHING SHARP EXTERNALLY OR POTENTIALLY FROM HARD CARTILAGE INTERNAL TO THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS IN USE, THE PATIENT EXPERIENCED A LOSS OF VENTILATION DUE TO A CUFF LEAK. THE SALINE LOSS WAS SEEN IN THE BRONCHIAL TUBE VISUALIZED WITH FIBROSCOPIC COLUMN. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282334 SMITHS MEDICAL BIVONA TUBES ADULT HYPERFLEX TTS TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3159593 15021312013825

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR