BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3942109 · Received March 4, 2014

    Report

    Report Number
    2936999-2014-00199
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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 STATES: DURING PREVENTATIVE CHECK NO FAILURE WAS SEEN BUT ONCE THE TUBE WAS INTUBATED AIR LEAKAGE WAS OBSERVED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129632 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1