BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOBRONCHIAL TUBE, ROBERTSHAW, LEFT, 37F

    MDR report key: 2901478 · Received January 3, 2013

    Report

    Report Number
    8040412-2013-00010
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 8, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINT IS REPORTED AS: THE BALLOON RUPTURED DURING USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3038 RUSCH ENDOBRONCHIAL TUBE, ROBERTSHAW, LEFT, 37F ENDOBRONCHIAL TUBE BTS TELEFLEX 12BE07

    Patients

    Seq Age Sex Outcome Treatment
    1