BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC TRANSMITTING STYLET

    MDR report key: 20799933 · Received November 27, 2024

    Report

    Report Number
    9611594-2024-00270
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    February 19, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 26-NOV-2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS "A [SECOND] COMPLETE RUPTURE OF DHT [DIGESTIVE HEALTH TUBE]. THIS TIME 50 CM OF TUBE WAS LEFT IN[SIDE OF THE] PATIENT. THE BEDSIDE RN [REGISTERED NURSE] DENIED ATTEMPTS TO UNCLOG." ADDITIONAL INFORMATION RECEIVED (B)(6) 2024 STATED THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE PROCEDURE IN THE OPERATING ROOM (OR) TO REMOVE THE RETAINED PORTION OF TUBE INSIDE THE PATIENT. ¿ PLEASE PROVIDE THE PATIENT INFO (DOB/GENDER/WEIGHT). THE DEVICE WAS PLACED (B)(6) 2024 AND REMOVED (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844804 CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC TRANSMITTING STYLET DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown