BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFFED FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 3981165 · Received July 23, 2014

    Report

    Report Number
    2183502-2014-00510
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 22, 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

    MANUFACTURER COMPLETED THE ENTIRE FORM. 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

    THE USER FACILITY REPORTED THAT FOLLOWING INSERTION OF THE TUBE THE PATIENT EXPERIENCED A "LOSS OF AIR." THE USER FACILITY REPORTED THAT THEY ATTEMPTED TO SUCTION THE TUBE, BUT EXPERIENCED DIFFICULTY PASSING AN 8FR SUCTION CATHETER THROUGH THE IN SITU TUBE. THE TUBE WAS THEREFORE REPLACED. NO PERMANENT ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432450 BIVONA TTS CUFFED FLEXTEND TRACHEOSTOMY TUBE JOH- TRACHEOSTOMY TUBE JOH SMITHS MEDICAL, INC. NA CS011684

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention