BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2170866 · Received July 13, 2011

    Report

    Report Number
    2170866
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 13, 2011
    Manufacturer
    COVIDIEN, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED AND THE INCIDENT OCCURRED THREE DAYS AFTER THE INITIAL INTUBATION PROCEDURE. THE PATIENT WAS ON A HIGH PRESSURE VENTILATOR. PATIENT WAS INTUBATED WITH A 7.5 ENDOTRACHEAL TUBE (ETT). PATIENT HAD BEEN SUCTIONED SEVERAL TIMES, BUT WITH ONLY SLIGHT AMOUNTS OF SECRETIONS OBTAINED. ON THE MORNING OF THE EVENT, HIGH PRESSURE ALARMS WERE SOUNDING. WATER WAS NOTED IN THE EXTERNAL BULB. ANESTHESIA HAD TO RE-INTUBATE. THE PATIENT WENT ASYSTOLIC DURING THIS EVENT AND REQUIRED MEDICATION AND CPR. UPON REMOVAL OF THE ETT TUBE, IT WAS NOTED TO HAVE CLOTTED OFF. RNS REPORT MULTIPLE ETTS HAVE BEEN CLOTTING. LOT NUMBERS AND PART NUMBERS OF THE TUBES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT TUBE, TRACHEAL BTR COVIDIEN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention