BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB ROBERTSHAW LEFT 26F

    MDR report key: 4054325 · Received August 15, 2014

    Report

    Report Number
    8040412-2014-00189
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    TELEFLEX MEDICAL EUROPE LTD
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FG
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT ONE OF THE CONNECTORS TO THE TUBE WAS BROKEN. THIS ALLEGED ISSUE WAS DETECTED AT THE TIME OF OPENING THE PACKAGE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491710 RUSCH EB ROBERTSHAW LEFT 26F BTS TELEFLEX MEDICAL EUROPE LTD 12CE11

    Patients

    Seq Age Sex Outcome Treatment
    1