BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TTS FLEX TEND RACHEOSTOMY TUBE

    MDR report key: 4092997 · Received September 5, 2014

    Report

    Report Number
    2183502-2014-00637
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    September 4, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE DEVICE WAS IN USE WITH THE PT FOR FIVE MINUTES, WHEN IT WAS DISCOVERED THAT THE SUCTION CATHETER WAS UNABLE TO PASS THROUGH THE TRACHEOSTOMY TUBE. TRACHEOSTOMY TUBE WAS REPLACED. NO ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546409 BIVONA CUSTOM TTS FLEX TEND RACHEOSTOMY TUBE JOH: TRACHEOSTOMY TUBE JOH SMITHS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK