BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 21478662 · Received February 27, 2025

    Report

    Report Number
    3011270181-2025-00003
    Event Type
    Injury
    Date Received
    February 27, 2025
    Report Date
    December 11, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K240965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 22100441, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 11-DEC-2025 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 21 CFR 803, 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27-FEB-2025 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 THE REGISTERED NURSE (RN) REPORTED PLACING A FEEDING TUBE IN A SIMILARLY CONFUSED PATIENT A WHILE BACK AND EVEN THOUGH THE RN SUSPECTED THE RECEIVER UNIT MOVED DURING THE PLACEMENT PROCEDURE. THE RN THOUGHT IT WAS GOOD ENOUGH. THE RN NOTED HAVING A DECENT TRACING AND FELT LIKE IT WAS A GOOD GASTRIC PLACEMENT BUT UPON X-RAY CONFIRMATION, IT WAS NOTED THAT THE FEEDING TUBE WAS IN THE LUNG AND CAUSED A PNEUMOTHORAX. THE RN ACKNOWLEDGED TAPING THE RECEIVER UNIT TO THE PATIENT'S GOWN. THE RN DID NOT UTILIZE THE LATERAL VIEW AND DEPTH CROSS SECTION VIEWS. IT IS NOT KNOWN WHEN THIS INCIDENT OCCURRED, AND THERE ARE NO STORED TRACING FILES ON THE DEVICE...IT IS ALSO NOT KNOWN IF THE PATIENT SUFFERED ANY OTHER HARM AS A RESULT OF THE PNEUMOTHORAX. ADDITIONAL INFORMATION RECEIVED 19-FEB-2025 STATING THE DEVICE [SOFTWARE] WAS NOT UPDATED TO 2.8 UNTIL 28-JAN-2025. THE CORTRAK WAS RUNNING ON AN OLDER SOFTWARE VERSION AT THE TIME OF THE INCIDENT; THE EXACT SOFTWARE VERSION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698015 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other