BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 1306393 · Received February 5, 2009

    Report

    Report Number
    2936999-2009-00060
    Event Type
    Injury
    Date Received
    February 5, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN AND THE TRACHEOSTOMY TUBE WAS DISCARDED, AND THEREFORE NOT AVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT HIS CUSTOMER STATES THAT THE DISPOSABLE INNER CANNULA (DIC) TRACHEOSTOMY TUBE IS EXTENDING BELOW THE DISTAL END OF THE OUTER CANNULA AND HAS CAUSED SOME BLEEDING IN THE PATIENT'S TRACHEA. NO OTHER INFORMATION WAS REPORTED AT THIS TIME. A FOLLOW UP PHONE CALL WAS MADE TO THE CALLER FOR ANY NEW ADDITIONAL INFORMATION, AND HE REPORTED THAT THE DOCTOR HAD REMOVED THE DIC TRACHEOSTOMY TUBE AND PLACED ANOTHER ONE IN THE PATIENT. THE CALLER STATED THAT THE DOCTOR DID NOT DO ANY TREATMENTS AND THERE WAS NO FURTHER REPORTS OF BLEEDING. THE REPORTED DIC THAT WAS REMOVED WAS DISCARDED AND THERE WAS NO LOT NUMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention