BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3880227 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00328
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    January 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RETURNED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NURSE TESTS THE CUFF BEFORE AN ANESTHETIST INSERTS THE TUBE INTO A POT'S AIRWAY. SHE INFLATE THE TRACHEAL CUFF AND THEN SHE TRIED TO DEFLATE IT. DURING THE PRETESTING PROCEDURE, THE AIR FROM THE BALLOONED TRACHEAL CUFF DID NOT COME OUT COMPLETELY. CUSTOMER REPORTED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211965 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown