BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA

    MDR report key: 1201491 · Received October 17, 2008

    Report

    Report Number
    2936999-2008-00518
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. RETURN OF TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TRACHEOSTOMY TUBE HAD A LEAK AND THE PT WAS RE-INTUBATED. THE CALLER REPORTED THAT THE HUB HAD COME OFF OF THE FLANGE AND THE PILOT LINE WAS STILL ATTACHED. THE REPORTER STATED THEY TRIED TO OVERINFLATE THE CUFF BECAUSE THEY COULD HEAR A LEAK WITH HISSING. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention