MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC; DH CORTRAK DISPOSABLES

Model Number	40-9431TRAK2
Medical Device Problem Codes	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• Brand Name: CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 25749199
• Report Number: 9611594-2026-00539
• Device Sequence Number: 13322613
• Product Code: KNT
• UDI-Device Identifier: 00350770460475
• UDI-Public: (01)00350770460475(240)120006266(17)310113(10)20136943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-9431TRAK2
• Device Catalogue Number: 40-9431TRAK2
• Device Lot Number: 20136943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown