BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK® 2 ENTERAL ACCESS SYSTEM (EAS) FEEDING TUBES

    MDR report key: 6283945 · Received January 27, 2017

    Report

    Report Number
    3009124963-2017-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 4, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THE NASOGASTRIC TUBE (NGT) WAS PLACED IN THE PATIENT ON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY SCAN (CT) WHICH SHOWED THE NGT WAS DISCONNECTED. THE NGT WAS REMOVED AND IT WAS NOTED TO BE BROKEN AT THE 45CM MARK. THE SEPARATED TUBE SEGMENT WAS NOTED IN THE LOWER INTESTINE. THE REGISTERED NURSE STATED THE PATIENT HAS AN X-RAY PERFORMED DAILY DUE TO MEDICAL CONDITIONS NOT RELATED TO THE NGT. NO MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN ORDERED TO LET THE NGT TUBE SEGMENT PASS WITH STOOL. NO INJURY OCCURRED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66153 CORTRAK® 2 ENTERAL ACCESS SYSTEM (EAS) FEEDING TUBES DH CORTRAK DISPOSABLES KNT HALYARD HEALTH 20-9551TRAK2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR