BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3093738 · Received April 30, 2013

    Report

    Report Number
    2936999-2013-00328
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON A PATIENT AT HOSPITAL, A NURSE CONFIRMED THE CUFF WOULD NOT DEFLATE. THE CUSTOMER CONFIRMED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS PERFORMED. AFTER EXTUBATION, AN AIR LEAKAGE FROM THE CUFF WAS CONFIRMED. CUSTOMER CONFIRMED NO PATIENT HARM. PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187164 MALLINCKRODT TAPERGUARD ORAL/ NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention