BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 2251560 · Received August 26, 2011

    Report

    Report Number
    2183502-2011-00595
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    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 ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER AN UNKNOWN AMOUNT OF TIME IN SITU THE TRACHEOSTOMY TUBE TORN NEAR THE FLANGE REQUIRING REPLACEMENT. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKK