BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH AGT NASAL CUFFED ET TUBE, 6.0MM

    MDR report key: 2802494 · Received October 18, 2012

    Report

    Report Number
    8040412-2012-00154
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 25, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON ON THE ENDOTRACHEAL TUBE WOULD NOT STAY INFLATED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH AGT NASAL CUFFED ET TUBE, 6.0MM ENDOTRACHEAL TUBE BSR TELEFLEX MEDICAL 10DE15

    Patients

    Seq Age Sex Outcome Treatment
    1