BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET, ENFIT

    MDR report key: 22292752 · Received June 19, 2025

    Report

    Report Number
    9611594-2025-00127
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 17, 2025
    Report Date
    December 31, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460475
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 19-JUN-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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE ACTUAL STOCK CODE IS 20-0950 AND NOT 40-9431TRAK2. NO ADDITIONAL INFORMATION WILL BE FILED UNDER REPORT NUMBER 9611594-2025-00127. ALL FUTURE DOCUMENTATION WILL OCCUR UNDER REPORT NUMBER 3011270181-2025-00055. ALL INFORMATION REASONABLY KNOWN AS OF 31-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 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 "PATIENT HAD AN ATTEMPTED CORTRAK PLACEMENT BY THE IV (INTRAVENOUS) TEAM. FAILED TO ADVANCE THE TUBE BEYOND 12 CM. RD (REGISTERED DIETICIAN) TEAM CONSULTED, AND THEY ALSO FAILED TO ADVANCE TUBE BEYOND 20CM. ENT (EAR NOSE AND THROAT) GROUP CONSULTED, AND THEY ALSO FAILED TO ADVANCE THE FEEDING TUBE. GI (GASTROINTESTINAL) TEAM CONSULTED, AND THE TUBE WAS PLACED AT 70CM BUT THE CONFIRMATION IMAGING INDICATED THE TUBE TIP WAS IN THE DISTAL ESOPHAGUS. THE PRIMARY TEAM WAS INSTRUCTED BY THE GI TEAM TO PULL BACK THE TUBE TO RELEASE THE SUSPECTED COIL. THE TUBE WAS COMPLETELY REMOVED. EITHER THE IV TEAM OR THE RAPID RESPONSE TEAM AGAIN ATTEMPTED A TUBE PLACEMENT AT THE BEDSIDE. THE RN (REGISTERED NURSE) PLACING THE TUBE CHARTED SOMETHING TO THE EFFECT: THE TUBE WAS ADVANCED TO 50CM BUT FELT RESISTANCE LIKELY DUE TO THE PATIENTS KNOWN HIATAL HERNIA. THE FOLLOW-UP IMAGING REVEALED THE TUBE WAS IN THE PATIENT'S RIGHT LUNG WITH EVIDENCE OF A PNEUMOTHORAX. THE RN ALSO CHARTED THE PATIENT TOLERATED THE PROCEDURE WELL." THE CORTRAK TRACING WAS REVIEWED WITH THE RD AND IT WAS CONCLUDED THIS RN MADE SEVERAL ATTEMPTS (GREATER THAN SIX CORTRAK TRACINGS), EACH TIME THE TUBE WAS SEEN DEVIATING FROM MIDLINE INTO THE PATIENT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724484 CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET, ENFIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9431TRAK2 UNKNOWN 00350770460475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CORTRAK EAS