BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 2903612 · Received January 2, 2013

    Report

    Report Number
    2183502-2012-00640
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 26, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN THE OPERATING ROOM. THE PATIENT RETURNED TO INTENSIVE CARE WHERE THE PATIENT BECAME DIFFICULT TO VENTILATE AND SHOWED SIGNS OF HYPERCARBIA. INVESTIGATION DEMONSTRATED THAT THE SURGEON HAD REQUESTED A TUBE WITH AN INNER DIAMETER OF 4.0MM BUT STAFF PROVIDED HER WITH A TUBE WITH AN OUTER DIAMETER OF 4.0MM AND AN INNER DIAMETER OF 2.5MM. WHEN THIS WAS DISCOVERED THE TUBE WAS REPLACED WITH A TUBE WITH THE CORRECT INNER DIAMETER. THE PATIENT RECOVERED WITH NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076 BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 1814088

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention