BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NG/NI FEED TUBE WITH ELECTRO STYLET, ENFIT

    MDR report key: 24593959 · Received March 13, 2026

    Report

    Report Number
    9611594-2026-00129
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Report Date
    March 13, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT 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 13-MAR-2026 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

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00130 FOR THE SECOND EVENT. THE CORTRAK DIGESTIVE HEALTH TUBE (DHT) WAS PLACED (B)(6) 2026. ON (B)(6) 2026 THE CORTRAK TEAM WAS CONSULTED FOR A CLOGGED TUBE. PER THE REGISTERED NURSE (RN) THEY ATTEMPTED TROUBLESHOOTING THE CLOG AND WHILE PULSATING HEARD A ¿POP.¿ THEY THEN STOPPED AND CONSULTED CORTRAK. A 60 ML SIZE SYRINGE WAS USED TO FLUSH THE TUBE. A NEW DHT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659446 CORTRAK 2 NG/NI FEED TUBE WITH ELECTRO STYLET, ENFIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female