BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINKCKRODT

    MDR report key: 3912444 · Received May 13, 2014

    Report

    Report Number
    2936999-2014-00415
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 16, 2014
    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 REPORTED, WHILE THE NURSE PROCESSED THE TRACHEAL CUFF BALLOONING TEST, SHE FOUND THE AIR LEAKED FROM THE BRONCHIAL CUFF. CUSTOMER CONFIRMED THAT FAULT WAS IDENTIFIED DURING PRETESTING EFFORTS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285622 MALLINKCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201303259X

    Patients

    Seq Age Sex Outcome Treatment
    1