BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3921917 · Received May 28, 2014

    Report

    Report Number
    2936999-2014-00453
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 28, 2017
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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: PRIOR TO USE, AT THE INSPECTION, THE CUFF INFLATED ASYMMETRY. THE STYLET WAS REMOVED AT THAT TIME. NO ADDITIONAL INFO WAS MADE AVAILABLE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314859 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT BTS COVIDIEN 201307381X

    Patients

    Seq Age Sex Outcome Treatment
    1