BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBRONCHIAL TUBES

    MDR report key: 3925694 · Received June 17, 2014

    Report

    Report Number
    2936999-2014-00497
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED BY THE AFFILIATE. AN INVESTIGATION IS ANTICIPATED, BUT NOT YET BEGUN. COVIDIEN REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT DURING FOLLOWING RE-POSITIONING OF THE PT, THE ENDOBRONCHIAL CATHETER'S PILOT BALLOON WAS DETACHED. IT WAS REPLACED BY ANOTHER SIMILAR DEVICE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356473 ENDOBRONCHIAL TUBES BTS COVIDIEN 125037 201401145X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention