BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGT ORAL CUFFED ET TUBE

    MDR report key: 1966811 · Received December 29, 2010

    Report

    Report Number
    8040412-2010-00117
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    November 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: BALLOON UNABLE TO BE INFLATED. ALSO, TUBING WAS FOUND BROKEN DURING USE. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGT ORAL CUFFED ET TUBE CUFFED ET TUBE JOH TELEFLEX MEDICAL NA 089KE45

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK