BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3955851 · Received June 25, 2014

    Report

    Report Number
    2936999-2014-00532
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OF INTERMEDIATE 86446 HI-LO ENDOTRACHEAL TUBE PART NUMBER WAS RECEIVED FOR EVALUATION, WITH NO LOT NUMBER PROVIDED. VISUAL INSPECTION AND PERFORMANCE TESTING DETERMINED THAT THE DEVICE WAS PERFORMING AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THERE WAS A LEAK WITH AND ENDOTRACHEAL TUBE. CUSTOMER DOES NOT KNOW THE LOT NUMBER OR THE MODEL NUMBER. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369871 SHILEY UNSPECIFIED ETT BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1