BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH HURST ESOPHAGEAL BOUGIE

    MDR report key: 2147060 · Received June 6, 2011

    Report

    Report Number
    3004365956-2011-00220
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW. RESULTS: A COMPLAINT HISTORY REVIEW FOR THE CATALOG NUMBER AND FAMILY OF PRODUCTS WAS REVIEWED FROM (B)(4) 2010 TO (B)(4) 2011. NO COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. CONCLUSIONS: USER ERROR CAUSED THE EVENT. INCORRECT USE OF DEVICE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A DOCTOR ACCIDENTLY CUT THE BOUGIE AND THE CONTENTS SPILLED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT CONDITION IS FINE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH HURST ESOPHAGEAL BOUGIE ESOPHAGEAL BOUGIE KCD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK