BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3113632 · Received May 9, 2013

    Report

    Report Number
    2936999-2013-00342
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 9, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON PT AT HOSPITAL, WHEN THE PT'S HAIR WAS SHAVED OFF, A NURSE FOUND THE PILOT BALLOON WAS DETACHED FROM THE TUBE. HE CONFIRMED THE INFLATION LINE WAS CUT OFF FROM THE BALLOON. CUSTOMER CANNOT CONFIRM THE CAUSE OF CUT. CUSTOMER CONFIRMED EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS PERFORMED. CUSTOMER CONFIRMED THE NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204954 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TU BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention