BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3812548 · Received May 2, 2014

    Report

    Report Number
    2936999-2014-00394
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. WITHOUT THE ACTUAL COMPLAINT SAMPLE BEING RETURNED FOR ANALYSIS WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT HOWEVER; PREVIOUS INVESTIGATIONS HAS BEEN PERFORMED RELATED TO CUFF INFLATION/DEFLATION AND INVESTIGATION EFFORTS HAVE BEEN ADDRESSED IN CORRECTIVE AND PREVENTATIVE ACTIONS. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND COMPLAINT TRENDS ARE REVIEWED MONTHLY TO DETERMINE IF ADDITIONAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER STATES: AFTER SEVERAL HOURS OF INTUBATION, LEAK OCCURRED AND THE TUBE WAS REPLACED. THE CUSTOMER REPORTED THAT FIVE DAYS LATER THE REPLACEMENT TUBE FAILED IN THE SAME MANNER. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265310 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention