BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE

    MDR report key: 3862998 · Received June 5, 2014

    Report

    Report Number
    2183502-2014-00378
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: 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 AND FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A LEAK WAS FOUND IN THE CUFF OF THE LISTED TRACHEOSTOMY TUBE AFTER 12 HOURS IN SITU. ACCORDING TO REPORTER, THE LEAK WAS FOUND WHEN THE VENTILATOR EMITTED AN ALARM; AN EMERGENT EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED AS A RESULT OF THE ALARM. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328842 BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention