BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3142937 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00412
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED OR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: AFTER 14 DAYS USE ON A PT AT HOSPITAL, THE ALARM OF LEAKAGE OCCURRED. EXTUBATION AND REINTUBATION WAS PERFORMED THEN A NURSE INSPECTED THE PRODUCT AND CONFIRMED THE AIR LEAKAGE FROM THE TUBE. THE CUSTOMER COULD NOT CONFIRM THE SOURCE OF THE LEAK. THE CUSTOMER STATED NO PT HARM AND CONFIRMED PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234099 MALLINCKRODT TAPERGUARD TRACHEAL TUBE BTR COVIDIEN 18780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention