BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM HYPERFLEX TRACHEOSTOMY TUBE

    MDR report key: 3983878 · Received June 23, 2014

    Report

    Report Number
    2183502-2014-00429
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    June 20, 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 MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT A TRACHEOSTOMY TUBE WAS FOUND LEAKING WHILE IN SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366088 BIVONA CUSTOM HYPERFLEX TRACHEOSTOMY TUBE JOH- TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK