BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 4190281 · Received October 21, 2014

    Report

    Report Number
    2936999-2014-00884
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 26, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED ENDOTRACHEAL TUBE WAS EVALUATED FOR THE REPORTED "CUFF WON'T INFLATE" ISSUE. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED A CUT BEHIND THE AREA WHERE THE INFLATION LINE IS INSERTED INTO THE TUBE. A INFLATION/DEFLATION TEST WAS PERFORMED. USING A SYRINGE, AIR WAS APPLIED TO THE CUFF. THE CUFF WAS OBSERVED TO IMMEDIATELY DEFLATE. THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING A TRACHEAL TUBE EXPERIENCED AN AIR LEAK WHILE BEING USED ON A PATIENT. THE AIR LEAK WAS DISCOVERED DURING A COMPUTED TOMOGRAPHY (CT) PROCEDURE. THE PATIENT WAS SUCCESSFULLY RE-INTUBATED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668547 MALLINCKRODT TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention