BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2932305 · Received January 24, 2013

    Report

    Report Number
    2936999-2013-00053
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEAL
    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

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON A PATIENT AT HOSPITAL, A NURSE CONFIRMED DROPS ACCUMULATED IN THE INFLATION LINE DURING THE INTUBATION AND IT PREVENTED THE FLOW OF AIR FROM THE CUFF. THE CUSTOMER CONFIRMED REPLACEMENT OF THE TUBE WAS REQUIRED. CUSTOMER CONFIRMED NO PATIENT HARM. PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34538 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCOHEAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention