BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM FLEXTEND FOME-CUF TRACHEOSTOMY TUBE

    MDR report key: 3883913 · Received June 12, 2014

    Report

    Report Number
    2183502-2014-00396
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THAT FOLLOWING ARRIVAL OF THE PATIENT AT THE HOSPITAL, FOR UNKNOWN REASON, THE PATIENT WAS INTUBATED USING THE LISTED TUBE. IMMEDIATELY UPON INTUBATION, THE CUFF WAS FOUND TO BE LEAKING. THE PATIENT'S OXYGEN SATURATION LEVEL WAS NOTED TO DECREASE SLIGHTLY BEFORE AN EMERGENT EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED. PATIENT'S MOTHER NOTED SOME TRAUMA TO THE PATIENT'S TRACHEA AND STOMA FOLLOWING THE EVENT. PATIENT REQUIRED ADMINISTRATION OF OXYGEN AND PAIN MEDICATION. NO PERMANENT ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347958 BIVONA CUSTOM FLEXTEND FOME-CUF TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBR JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention