BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT-PR

    MDR report key: 8105913 · Received November 27, 2018

    Report

    Report Number
    1282497-2018-08181
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    September 26, 2018
    Report Date
    February 26, 2019
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE SAMPLE WAS NOT RETURNED, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. NO ROOT CAUSE IDENTIFIED BECAUSE SAMPLE WAS NOT RETURNED. DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE LOT NUMBER AND PRODUCT NUMBER WAS NOT REPORTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE MOUTHPIECE OF THE TUBING THAT IS FIXED ON THE GPE CRACKS WHEN THE TIP OF THE PROBE IS SCREWED ON; THIS CAUSES A LEAK. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947807 UNKNOWN PRODUCT-PR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN UNKNOWN PRODUCT-PR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1