BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 4193642 · Received October 22, 2014

    Report

    Report Number
    2936999-2014-00883
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ENDOBRONCHIAL TUBE WAS EVALUATED. THE BATCH RECORD FOR THE REFERENCED LOT WAS REVIEWED AND CONFIRMED ALL QUALITY REQUIREMENTS WERE MET AT THE TIME OF MANUFACTURING. FURTHER VISUAL EXAMINATION OF THE CUFF SHOWED A CUT, MEASURING 5.01 MM IN LENGTH AND 0.87 MM AT ITS WIDEST POINT. THIS TYPE OF DEFECT IS INDICATIVE OF THE RETURNED UNIT COMING IN CONTACT WITH A SHARP OBJECT. THE SOURCE OF THE CUT CANNOT BE DETERMINED AT THIS TIME. A CAPA HAS BEEN INITIATED FOR THE REPORTED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING AN ENDOBRONCHIAL TUBE'S CUFF WOULD NOT INFLATE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671547 MALLINCKRODT ENDOBRONCHIAL TUBE BTO COVIDIEN 201402001X

    Patients

    Seq Age Sex Outcome Treatment
    1