BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOBRONCHIAL TUBE, ROBERSHAW, LEFT 39F

    MDR report key: 4180354 · Received October 15, 2014

    Report

    Report Number
    8040412-2014-00236
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    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 COMPLAINT IS REPORTED AS: "WHEN THE NURSE OPENED THE DEVICE, HE NOTICED THAT IT WAS DEFECTIVE BECAUSE THE PART OF THE DEVICE THAT IS USED TO INFLATE THE BALLOON "TRANSPARENT" (TRACHEAL) WAS SEPARATED FROM THE TEST OF THE DEVICE." THE INCIDENT OCCURRED IN THE OPERATING ROOM. THERE WAS NO CONSEQUENCE TO THE PT AS IT OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656236 RUSCH ENDOBRONCHIAL TUBE, ROBERSHAW, LEFT 39F ENDOBRONCHIAL TUBE BTS TELEFLEX 13LT14

    Patients

    Seq Age Sex Outcome Treatment
    1