BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MALONEY ESOPHAGEAL BOUGIE 58F

    MDR report key: 2672065 · Received July 18, 2012

    Report

    Report Number
    3004365956-2012-00244
    Event Type
    Malfunction
    Date Received
    July 18, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE SAMPLE. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: DURING AN ENT PROCEDURE, THE BOUGIE WAS CAUGHT AT THE END OF A LARYNGOSCOPE AND SOME OF THE BLACK CONTENTS FROM THE BOUGIE BURST INSIDE THE PT." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH MALONEY ESOPHAGEAL BOUGIE 58F ESOPHAGEAL BOUGIE KCD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1