BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH HURST ESOPHAGEAL BOUGIE 3

    MDR report key: 3769248 · Received January 9, 2014

    Report

    Report Number
    3004365956-2014-00013
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE HAS NOT BEEN RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE DEFECTIVE SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS A PREVENTIVE ACTION THE INVOLVED PRODUCTION AND QUALITY PERSONNEL WERE INFORMED ABOUT THIS COMPLAINT. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE SAMPLE. BASED ON THE DESCRIPTION OF THE COMPLAINT IT WAS STATED THAT THE DOCTOR CUT IT WITH A STAPLING INSTRUMENT THEREFORE IT IS UNKNOWN THE METHOD USED BY CUSTOMER. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. THIS COMPLAINT WAS NOTIFIED TO THE PERSONNEL INVOLVED ON THE MANUFACTURING PROCESS. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: ALLEGED ISSUE: A PT WAS HAVING A MEDICAL PROCEDURE USING A MALONEY RUSCH TUNGSTEN FILLED BOUGIE AND THE DOCTOR CUT IT WITH A STAPLING INSTRUMENT WHERE THE TUNGSTEN CAME OUT INTO THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17828 RUSCH HURST ESOPHAGEAL BOUGIE 3 BOUGIE KCD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1