BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 2146425 · Received June 24, 2011

    Report

    Report Number
    2183502-2011-00498
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE CUSTOMER'S REPORT OF A BROKEN TRACH IS CONFIRMED. VISUAL INSPECTION NOTED EXPOSED WIRES ON THE PEDI TRACH SHAFT LOCATED NEAR THE NECKSTRAP. EXAMINING THE MANNER IN WHICH THE SHAFT SPLIT IT APPEARS AS THOUGH EITHER AN INSTRUMENT WAS USED WHEN HANDLING THE DEVICE OR THE DEVICE WAS NOT HANDLED PROPERLY DURING CLEANING AND REPROCESSING. THE ROOT CAUSE OF THE BROKEN SHAFT IS CONSIDERED TO BE A RESULT OF THE CUSTOMER/ USER INTERFACING WITH THE PRODUCT IN A MANNER INCONSISTENT WITH THE IFU. THE DEFECT WAS NOT DETERMINED TO BE A MFG DEFECT.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER SIX DAYS IN SITU, THE TRACHEOSTOMY TUBE WAS 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 TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1