BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3142916 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00397
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 30, 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 IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON A PT AT HOSPITAL, A SUPPLIER CONFIRMED THE AIR LEAKAGE OCCURRED. THE CUSTOMER STATES THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. VISUAL INSPECTION OF THE REMOVED TUBE DID NOT CONFIRM ANY DAMAGE TO THE CUFF. CUSTOMER CONFIRMED NO PT HARM AND CONFIRMED PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233919 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention