MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	20-0950
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pneumothorax (2012); Cough (4457)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Monitor serial number: (b)(6), software 2.8.0.Receiver serial number: (b)(6), model version 1.1.0.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.
Event or Problem Description
It was reported the patient was "admitted to hospital (b)(6) 2025." the patient was on ten liters of oxygen (02) via face mask at the time of feeding tube placement.The cortrak tube placement attempt was performed on (b)(6) 2025.Per hospital policy a carbon dioxide (co2) detector was used during placement.The "first attempt, tracing with time stamp 15:09, registered nurse (rn) "reports co2 detector showed color change indicating tube was in the lung, "[patient]" also coughing during first attempt and tube was removed.Anterior view shows tube tip deviation to the right in the upper quadrant." the "second tracing, time 15:12, duration 43 seconds.Rn used a new co2 detector for this placement."[communication with]" to rn who reports "[patient]" did not cough, stats were stable, no drop in oxygen (spo2), co2 detector did not have color change to indicate tube was in the lung.Anterior view shows tube deviates to the right.Rn states she was concerned with the tracing on the anterior view, however, the co2 detector did not indicate she was in the lung and "[patient]" did not have any other signs and symptoms to indicate she was in the lung and assumed the receiver was not in the correct position." the "third tracing, time 15:12, duration 12 seconds.Rn retraced tube and also had "[patient's]" rn use auscultation to assess if tube was in correct position, states air was heard in the patient¿s stomach.Per hospital policy a chest "[x-ray]" was ordered to confirm placement.Initial "[x-ray]" show tube in the "[right]" lung.Tube was removed upon findings on "[x-ray]".Second "[x-ray]" shows "[patient]" now has small "[right]" apical pneumothorax." further events sequence are as follows: on (b)(6) 2025 at 16:34: weighted feeding tube tip projects over the right lung with tip likely in the pleural space.No pneumothorax detected, though is at risk for pneumothorax on removal tube.On (b)(6) 2025 at 18:13: small right apical pneumothorax.Patient did not require a chest tube, attempt to place another feeding tube was not made by cortrak operating room radiology.On (b)(6) 2025 at 06:24: stable small right apical pneumothorax without cardiomediastinal shift on (b)(6) 2025 at 08:24: resolved pneumothorax.' palliative care was consulted on (b)(6) 2025 and "[patient]" died on (b)(6) 2025.Death was not "[due to]" cortrak misplacement according to report." additional information received 03-feb-2025 stated the patient was not intubated at time of tube placement.
Additional Manufacturer Narrative
(b)(6).The device history record for the reported lot number, 22122031, 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 17-jun-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.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MINNETRONIX, INC.; 1635 energy park dr.; saint paul MN 55108
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21479442
• Report Number: 3011270181-2025-00002
• Device Sequence Number: 3983156
• Product Code: KNT
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K240965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 20-0950
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 40-9551TRAK2; RU SN (B)(6).; RU SN 22120142
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 132 LB