BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 22461976 · Received July 9, 2025

    Report

    Report Number
    3011270181-2025-00024
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    May 27, 2025
    Report Date
    December 23, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION HOWEVER; DEVICE TRACINGS HAVE BEEN RETURNED FOR REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 AND D10. SOFTWARE VERSION: V2.8. THE SAMPLE IS REPORTEDLY AVAILABLE FOR THIS COMPLAINT BUT WAS NOT RETURNED WHEN THIS REPORT WAS FILED. ALL INFORMATION REASONABLY KNOWN AS OF 23-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.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2025-00023 FOR THE FIRST REPORT IT WAS REPORTED, LUNG PLACEMENT WITH CORTRAK UNIT. ¿THE PATIENT WAS ALERT AND ORIENTED AND SHOWED NO SIGNS OF COUGHING/ SHORTNESS OF BREATH (SOB) UNTIL OXYGEN SATURATIONS STARTED TO DROP. THE TWO TRAINED CORTRAK RNS STATED AFTER THE PROCEDURE THAT THEY WERE HAVING DIFFICULTY WITH THE DEVICE. THEY STATED THAT EVERY TIME THEY TRIED TO ADVANCE THE TUBE, THE GREEN DOT WOULD NOT MOVE. THE GREEN DOT STAYED POSITIONED AT THE TOP OF THE SCREEN "BOUNCING" AS IF IT WAS COILING IN THE THROAT. THEY PULLED BACK AND ATTEMPTED TO ADVANCE SEVERAL TIMES, AS THE TUBE DID NOT EVER APPEAR TO MOVE. WHEN THE TUBE TRACING DID MOVE, IT MOVED VERY QUICKLY, NOT IN ASSOCIATION WITH THEIR "ADVANCING" AND APPEARED BOTH TIMES, SPONTANEOUSLY IN WHAT APPEARED TO BE THE LOWER LUNG. THEY REMOVED THE TUBE BOTH TIMES AND CALLED FOR ASSISTANCE. THE PATIENT DEVELOPED A PNEUMOTHORAX AND NEEDED A CHEST TUBE. THE PATIENT DID RECOVER. NO DEATH. DISCHARGED TO REHAB. CORTRAK 2 EAS IS RUNNING NEW SOFTWARE. THERE WAS A SIGNIFICANT LAG FROM THE TUBE MOVING TO THE TRACING ON THE DEVICE... NO OUT-OF-RANGE MESSAGE WAS DISPLAYED.¿ PATIENT WAS NOT INTUBATED AT TIME OF PLACEMENT, NO ATYPICAL ANATOMY REPORTED. NO IMPLANTED MEDICAL DEVICES WITH ELECTROMAGNETIC INTERFERENCE. NO COMORBIDITIES. LEFT LUNG PNEUMOTHORAX TREATED WITH CHEST TUBE. THIS TUBE WAS NEVER PLACED INTO THE STOMACH AND USED. INCIDENT DISCOVERED DUE TO PATIENT BECOMING SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465920 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| O RU 23030452