BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 1130983 · Received August 20, 2008

    Report

    Report Number
    2936999-2008-00401
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A F/U REPORT WILL BE SUBMITTED. A MFG CAPA IS ALREADY IN PLACE TO INVESTIGATE THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE CALLER REPORTED A HOSP HAD A BOX OF 8 DIC TRACHEOSTOMY TUBES AND 2 OF THEM WERE LABELED FOR AN 8 BUT WERE ACTUALLY A 6. HE STATED THAT ONE OF THE MISLABELED DIC TRACHEOSTOMY TUBES WAS USED ON A PT. IT WAS IMMEDIATELY SEEN THAT IT WAS THE INCORRECT SIZE AND WAS DISPOSED OF. THE SECOND TUBE ALSO MISLABELED WAS RETAINED AND BEING REPORTED SEPARATELY ON REPORT 2936999-2008-00402.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCO 0805002254

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention