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); Low Oxygen Saturation (2477)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "there was a possible perforated esophagus into pleura." a kub [(kidney, ureter, and bladder) was taken prior to feed initiation, feeds were initiated and a chest drain had to be placed." additional information received 20-mar-2025 stating the patient had cortrak inserted.A kub was performed to verify placement."the patient was transferred to a telemetry floor.Overnight the patient had increased [oxygen] o2 needs.On (b)(6) 2025, the chest x-ray revealed the cortrak was in the lung.The patient received tube feed in the hours prior to the discovery.The patient ultimately required intubation.A follow up chest x-ray showed a pneumothorax, and a chest tube was inserted.The patient remained intubated and sedated until a compassionate wean decision was made by the family." additional information received 21-mar-2025 stating the date of expiration is unknown "as the patient was transferred to hospice on [(b)(6) 2025].".
Additional Manufacturer Narrative
Software version: 2.8.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 03-apr-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
The device history record for the reported lot number, 20040411, 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 05-feb-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: 21766046
• Report Number: 3011270181-2025-00008
• Device Sequence Number: 15601259
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: (01)00350770472010(240)104720110
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K240965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/05/2026

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: UNKNOWN
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 66 KG