BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 11098798 · Received December 30, 2020

    Report

    Report Number
    3012307300-2020-12877
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    November 27, 2020
    Report Date
    December 31, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312013801
    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

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX TTS . THE COMPLAINT CUFF LEAKING WAS CONFIRMED WHEN LEAK PROCEDURE WI-10-012, 15CC OF AIR WAS APPLIED TO THE DEVICE AND A SLOW LEAK DETECTED ON CUFF. VALIDATED USING MAGNIFICATION A HOLE WAS FOUND NEAR HE PROXIMAL END OF CUFF WITH PHOTO ATTACHED. TWO CUFFS WERE REPORTED LEAKING WITH ONLY ONE DEVICE RETURNED. THE MANUFACTURING REVEALED ALL DEVICE PASSED AT 100% PRIOR TO RELEASE. COMPLAINT REVEALED LEAK, UNKNOWN CAUSE OF EVENT.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX TTS TUBE LEAKED AFTER TWO DAYS IN USE. A SECOND CUFF WAS INSERTED AND AFTER TWO DAYS IN USE THE SECOND CUFF WAS INSERTED LEAKED AGAIN. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559137 BIVONA TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 7.0MM 3939458 15021312013801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention