BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 12005793 · Received June 15, 2021

    Report

    Report Number
    3012307300-2021-06086
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    March 2, 2020
    Report Date
    June 20, 2023
    Manufacturer
    ST PAUL
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND . REPORTED THREE SAMPLES RECEIVED FROM 67NFPS30, LOTS 4080786 AND 4095914. WHEN THE SAMPLES WERE INFLATED WITH AIR, THE PILOT BALLOON INFLATED, BUT ALL THE AIR WAS STUCK IT. ACCORDING TO THE IFU (10018859-001 REV.100, INSTRUCTION FOR USE: BIVONA TTS FLEXTEND TRACHEOSTOMY)) THE PILOT BALLOON WAS MANIPULATED, AND THE CUFF INFLATED. AFTER THE WHOLE CUFF INFLATED, IT WAS DEFLATED AND INFLATED 4 TIMES, ALL THE TIMES THE CUFF INFLATED COMPLETELY AND SYMMETRICALLY. THE COMPLAINT IS NOT CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED, SINCE THE SAMPLE SUCCESSFULLY PASSED FUNCTIONAL TEST.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED WITH SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND CUFFS WERE NOT INFLATING WHEN TESTED. THE REPORT BY A NURSE STATED THE BABY WAS HAVING RESPIRATORY STATUS WORSENING WITH FEEDING AND OXYGEN NEEDED TO BE INCREASED WITH PATIENT SUCTIONED AND PERCUSSED SUPINE AND PRONE. RTT WAS SUMMONED AND A TRACH CHANGE WAS DONE, AFTER FOUR TIMES TRYING THE PATIENT REQUIRED ATROVENT EXTRA DOSE WITH REPORT OF PATIENT RESTING COMFORTABLE AFTER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893534 BIVONA TRACHEOSTOMY JOH ST PAUL 4080786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention