BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 11120303 · Received January 5, 2021

    Report

    Report Number
    3012307300-2021-00085
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    May 29, 2020
    Report Date
    January 5, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688518699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND COMPLAINT OF INFLATION AT THE BESIDE WITH RT REPLACING TRACHEOSTOMY TUBE DUE TO INFLATION PROBLEM WAS NOT CONFIRMED. THE PRODUCT P/N 67PFSS40 L/N 3894875 WAS OBSERVED. NO DAMAGE COULD BE DETECTED. PRODUCT TESTING WITH 5CC OF AIR ACCORDING TO MP BIVONA TT-TJ110 REV. 111 FLEXTEND TTS TRACHEOSTOMY TUBE ASSEMBLY" IN ORDER TO SEE IF THERE WAS ANY FUNCTIONAL PROBLEM. CUFF INFLATED AFTER MANIPULATING PILOT BALLOON. THEN THE CUFF WAS DEFLATED FOUR TIMES WITH ALL TIMES THE CUFF INFLATED COMPLETELY. NO FAULT FOUND AS UNABLE TO DUPLICATE EVENT.

    Description of Event or Problem · 1

    INVESTIGATION COMPLETED AND SUMMARIZED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17961 BIVONA JOH SMITHS MEDICAL ASD, INC. 67PFSS40 3894875 10351688518699

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention