BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE

    MDR report key: 9304976 · Received November 11, 2019

    Report

    Report Number
    3012307300-2019-06307
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 11, 2019
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    UDI-DI
    15021312013825
    PMA / PMN Number
    K081440
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PNEUPAC VENTILATOR WAS RETURNED IN GOOD CONDITION. THE UNIT WAS TURNED ON FOR FUNCTIONAL TESTING AND WAS OBSERVED TO BE WORKING AS INTENDED. BASED ON THE EVIDENCE, THE COMPLAINT WAS NOT CONFIRMED. ONE BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED A BLACK PIECE OF TAPE WAS FOUND ON THE CUFF AND TWO MARKS ON THE CUFF. THE CUFF WAS THEN INFLATED WITH AIR BUT WAS OBSERVED TO DEFLATE WITHIN ONE MINUTE. THE DEVICE WAS THEN PUT THROUGH LEAK TESTING; THE LEAK WAS FOUND TO BE LEAKING NEAR THE RIGHT SIDE OF THE TAPE. MAGNIFICATION WAS USED TO INSPECT THE CUFF; ABRASIONS WERE FOUND ON THE CUFF. BASED ON THE EVIDENCE THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS FOUND TO BE USER INTERFACE AS THE ABRASIONS WERE LIKELY DUE TO REPOSSESSING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE WAS FOUND TO BE BROKEN SIX HOURS AFTER USE. IT WAS REPORTED THAT THE TUBE HAD BEEN REMOVED FOR REPOSSESSING PRIOR TO REINSERTION. THE TRACH TUBE WAS REMOVED AND RETURNED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100334 BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC. 2081250 15021312013825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention