BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2873450 · Received December 11, 2012

    Report

    Report Number
    2936999-2012-00651
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTH CARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES DURING USE ON A PATIENT, A NURSE CONFIRMED THE INFLATION LINE WAS CUT. CALLER CONFIRMED NO PATIENT HARM AND CONFIRMED PRETESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention