BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2914905 · Received January 9, 2013

    Report

    Report Number
    2936999-2013-00021
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    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

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATES: AFTER 1 HOUR USE ON A VENTILATED PATIENT AT HOSPITAL, A NURSE CONFIRMED THE AIR LEAKAGE OCCURRED. CUSTOMER CONFIRMED THAT THE NO ROUTINE REPLACEMENT WAS PERFORMED AND THE ISSUE WAS RESOLVED. CUSTOMER CONFIRMED NO HARM TO THE PT. THE CUSTOMER COULD NOT CONFIRM THE SOURCE OF THE LEAK. SHE REPLACED IT AND THEN CONFIRMED THE PROBLEM WAS SOLVED. CUSTOMER CONFIRMED PRE-TESTING WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12068 MALLINCKRODT TAPERGUARD EVAC TRACHEAL BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention