BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3912447 · Received May 13, 2014

    Report

    Report Number
    2936999-2014-00418
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    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 THAT WHILE CONDUCTING THE CUFF BALLOON TEST, A NURSE OBSERVED AIR LEAKING FROM THE CUFF. THERE WAS NO PATIENT INVOLVEMENT AS FAILURE WAS DISCOVERED DURING PRE-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285710 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN 13D0889JZX

    Patients

    Seq Age Sex Outcome Treatment
    1