BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOMER TTS FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 3901010 · Received June 17, 2014

    Report

    Report Number
    2183502-2014-00409
    Event Type
    Injury
    Date Received
    June 17, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A TRACHEOSTOMY TUBE FLANGE SPLIT WHILE IN USE WITH A PATIENT AFTER AN UNKNOWN AMOUNT OF TIME. AN EMERGENT TRACHEOSTOMY TUBE EXCHANGE WAS REQUIRED. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356791 BIVONA CUSTOMER TTS FLEXTEND TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL, INC. NA CS011521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention