BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE LOW PRESSURE CUFFED

    MDR report key: 1081180 · Received July 23, 2008

    Report

    Report Number
    2936999-2008-00325
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 25, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. NO CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS IN INTENSIVE CARE WITH AN 8DCT TRACHEOSTOMY TUBE. THE PT WAS RECEIVING ROUTINE TRACHEOSTOMY CARE WHEN IT WAS NOTED THAT ONE SIDE OF THE FLANGE HAS SEPARATED FROM THE HUB. THE PATIENT WAS NOT IN ANY DISTRESS. THE TUBE WAS REMOVED AND A NEW 8DCT WAS INSERTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE LOW PRESSURE CUFFED TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCO HEALHCARE 0712001372

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention