BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA PEDIATRIC CUFFLESS TRACHEOSTOMY TUBE

    MDR report key: 302851 · Received October 31, 2000

    Report

    Report Number
    1824231-2000-00004
    Event Type
    Other
    Date Received
    October 31, 2000
    Date of Event
    October 9, 2000
    Report Date
    October 31, 2000
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRACHEOTOMY TUBE RETURNED TO FACILITY BY PARENTS OF CHILD WHO HAS A TRACHEOTOMY TO ADDRESS OBSTRUCTIVE SLEEP APNEA. THE PARENTS REPORT THIS TUBE WAS PLACED IN PT IN 2000. THE PARENT NOTICED THAT NIGHT, MONDAY NIGHT AND TUESDAY NIGHT THAT PT WAS SNORING AND VERY RESTLESS DURING SLEEP. THEY ATTEMPTED TO SUCTION PT WITHOUT RESOLUTION OF THE SYMPTOMS. PT WAS REPORTED TO EXPERIENCE RESPIRATORY DISTRESS SIGNIFICANTLY ENOUGH ON TUESDAY MORNING TO REQUIRE THE PARENTS TO CHANGE THE TRACH TUBE. PT IMPROVED SIGNIFICANTLY AFTER THE TUBE CHANGE AND IS NOW DOING WELL. THE PARENTS SUBSEQUENTLY ATTEMPTED TO CLEAN THE TUB AND NOTICED A "FLAP" IN THE LUMEN OF THE TUBE. THIS DID NOT APPEAR TO BE A MUCUS PLUG BUT RATHER A FLAP OF SILICONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA PEDIATRIC CUFFLESS TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention