BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3760778 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00315
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT AFTER THIRTY DAYS OF PT USE A NURSE NOTICED A LEAKAGE IN THE CUFF. THE INFO PROVIDED SUGGEST THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210486 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention