BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE

    MDR report key: 3676782 · Received February 26, 2014

    Report

    Report Number
    2936999-2014-00181
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    November 6, 2013
    Report Date
    January 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS IN THE PROCESS OF OBTAINING FURTHER INFO SURROUNDING THE CIRCUMSTANCES OF THIS REPORT, INCLUDING SAMPLE RETURN. IF THE SAMPLE IS REC'D, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    COVIDIEN REC'D A MAUDE REPORT (B)(4) REPORTING THE ENDOTRACHEAL TUBE SNAPPED AND BROKE. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS ASSOCIATED TO THE CIRCUMSTANCES OF THIS REPORT. INVESTIGATION EFFORTS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117877 ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR COVIDIEN 13G026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention