BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3901777 · Received May 2, 2014

    Report

    Report Number
    2936999-2014-00396
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    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 FOR THE ANALYSIS, RESULTS OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS STILL SOME AIR IN THE CUFF ALTHOUGH THE CUFF DEFLATED BEFORE INTUBATION. THE CUSTOMER REPORTED THIS WAS DISCOVERED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265468 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1