BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3113633 · Received May 9, 2013

    Report

    Report Number
    2936999-2013-00341
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 9, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES: NO PROBLEM WAS CONFIRMED AT PRE-TEST. INTUBATION WAS PERFORMED BY USAGE OF AIRWAY SCOPE. CUSTOMER STATED ONE MINUTE AFTER INTUBATION ON PT AT HOSPITAL, A DOCTOR OBSERVED AN AIR LEAKAGE. THE CUSTOMER CONFIRMED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. CUSTOMER REPORTED THAT VISUAL INSPECTION OF THE REMOVED TUBE CONFIRMED THE AIR LEAKAGE OCCURRED FROM THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202814 MALLINCKRODT ENDORONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201211252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention