BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3853143 · Received April 2, 2014

    Report

    Report Number
    2936999-2014-00309
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 14, 2025
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: BEFORE USE, A NURSE TESTED CUFF OF THE TUBAL AND INFLATED THE TRACHEAL CUFF BUT THE CUFF WOULD NOT DEFLATE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199791 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201303154X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown