BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 3964863 · Received July 17, 2014

    Report

    Report Number
    2183502-2014-00499
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K083641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    A REPORT WAS RECEIVED STATING THE DEVICE WAS IN USE WITH A PATIENT WHEN IT WAS OBSERVED THAT THE TRACHEOSTOMY TUBE WAS NOT SITTING PROPERLY IN THE PATIENT'S TRACHEA. AN EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420477 BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE JOH-TRACHEOSTOMY TUBE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention