BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 11611920 · Received April 4, 2021

    Report

    Report Number
    3012307300-2021-02817
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Report Date
    May 18, 2021
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED TTS COMPLAINT OF CUFF NOT INFLATING WAS NOT CONFIRMED. TWO SAMPLES /N 67P055 L/N 3942457 AND P/N 67P055 L/N 3936569 WERE USED FOR TESTING . THE RESULTS REVEALED AFTER CUFF MANIPULATED PER IFU (10018853-001 REV.100, INSTRUCTIONS FOR USE - PEDI NEO TTS IFU (PNT)), THE CUFF WAS MANIPULATED, AND IT WAS INFLATED COMPLETELY. AFTER THE WHOLE CUFF INFLATED, IT WAS DEFLATED AND INFLATED 4 TIMES, ALL THE TIMES THE CUFF INFLATED COMPLETELY. WHEN THE CUFFS WERE MEASURED, THE PERCENTAGE FOR THE SYMMETRY WAS FOR SAMPLE 1:45PERCENT AND SAMPLE 2:47PERCENT THESE RESULTS ARE OVER 33.PERCENT THAT IS THE MINIMUM ACCEPTABLE. BASED ON THE TEST, THE UNITS ARE WITHIN SPEC. THE COMPLAINT IS NOT CONFIRMED. DEVICE PASSED AT 100PERCENT PRIOR TO RELEASE. NO ROOT CAUSE WAS ESTABLISHED.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER HAS PROBLEMS WITH 4 SMITHS MEDICAL TRACH TUBES. THE FIRST TRACH WAS TESTED AND THE PILOT BALLOON INFLATED BUT THE CUFF DID NOT. THE SECOND TRACH WAS TESTED AND IT INFLATED ASYMMETRICALLY WITH PART OF THE CUFF BEING STUCK TO THE TUBE. THE OTHER TWO TUBES CAUSED TIDAL VOLUMES TO ALARM. THE CUFF WAS LEAKING BOTH TIMES AND THE PATIENT HAD TO HAVE A TRACH CHANGE DONE EACH OF THE TWO TIMES TO RESOLVE THE ISSUE. THE THIRD TRACH THAT WAS PUT IN, WAS GOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509309 BIVONA TRACHEOSTOMY TUBE JOH 67P055

    Patients

    Seq Age Sex Outcome Treatment
    1