BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE

    MDR report key: 3833378 · Received May 16, 2014

    Report

    Report Number
    2183502-2014-00304
    Event Type
    Injury
    Date Received
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION NONCE IT IS COMPLETED. METHOD: A SAMPLE DEVICE WAS RETURNED AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED DEVICE WAS IN USE WHEN A CRACK IN THE INFLATION LINE WAS DETECTED. THE TRACHEOSTOMY TUBE WAS REPLACED, EMERGENTLY. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293594 BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE JOH-TRACHEOSTOMY TUBE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention