BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1222525 · Received November 6, 2008

    Report

    Report Number
    2936999-2008-00510
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN AND THE TUBE WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE LOT NUMBER BECOMES AVAILABLE FOR FURTHER INVESTIGATION, THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS AND A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ANY SIGNIFICANT INFORMATION RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT THE THERAPIST NOTED A LEAK EITHER BY HEARING OR BECAUSE IT WAS TRIGGERING THE LOW PRESSURE ALARM ON THE VENTILATOR. THE CALLER STATED THAT INITIALLY THE PATIENT WAS CHECKED FOR A CUFF LEAK BUT NONE WAS FOUND. ON CLOSED EXAMINATION THEY FOUND THAT THE CONNECTOR HAD BROKEN AWAY FROM THE OUTER CANNULA. THE TRACHEOSTOMY TUBE WAS REMOVED AND ANOTHER 8DCT WAS INSERTED WITHOUT ISSUE. THE PATIENT HAD TO BE RE INTUBATED. THE CALLER IS NOT SURE BUT THINKS THE TRACHEOSTOMY TUBE WAS IN ABOUT THREE WEEKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention