BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3811987 · Received April 30, 2014

    Report

    Report Number
    2936999-2014-00374
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCING RELATED MEDWATCH REPORT # 2936999-2014-00373, 2936999-2014-00375, 2936999-2014-00376.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED MEDWATCH REPORT (B)(4) STATING AFTER INTUBATION, THE PATIENT'S OXYGEN SATURATION DECREASED AND THE PATIENT'S SKIN BECAME "ASHEN" COLORED DUE TO A CUFF LEAK IN THE ENDOTRACHEAL TUBE. THE INFORMATION PROVIDED SUGGEST THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258632 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention