BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3902635 · Received May 9, 2014

    Report

    Report Number
    2936999-2014-00431
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    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 RHE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TRACHEAL CUFF WAS INFLATED PRIOR TO USE AND THE CUFF WOULD NOT INFLATE. THE CUSTOMER CONFIRMED THAT THE PRODUCT WAS NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282370 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1