BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA

    MDR report key: 2190851 · Received July 26, 2011

    Report

    Report Number
    2936999-2011-00504
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE SAMPLE FOR INVESTIGATION NO CONCLUSIONS CAN BE MADE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE PT HAD A TRACHEOSTOMY PLACED AT THE BEDSIDE AND THE FLANGE WAS NOTED TO BE BROKEN LESS THAN 10 MINUTES AFTER USE. THE PROCEDURE WAS A BEDSIDE PERCUTANEOUS TRACHEOSTOMY. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW TRACHEOSTOMY TUBE OF THE SAME SIZE AND MANUFACTURER. THE BROKEN TRACHEOSTOMY TUBE WAS INADVERTENTLY DISCARDED AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1008000831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention