MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FEEDING TUBE ELECTROMAGNETIC TRANSMITTING STYLET WITH ENFIT; DH CORTRAK DISPOSABLES

Model Number	40-9551TRAK2
Medical Device Problem Codes	Complete Blockage (1094); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initially deemed not reportable based on our reporting strategy active at the time of the alert date; however, following a recent retrospective review of complaints this event was made reportable out of an abundance of caution.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The actual complaint product was returned for evaluation.There are no visible tears, cuts or holes in the tubing.An attempt was made to flush water through, using a 35ml enfit syringe attached to the central port.The side port was closed.When the plunger was pressed on the syringe, complete resistance was encountered.Firmness was felt between the 2cm and 4cm depth markers.The tubing was cut in that area.Some dried matter was observed but not a full occlusion.Another cut was made between the 42cm and 43cm depth markers.The tubing is fully occluded by dried matter.A root cause has not been determined.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidents, which were associated with separate units, involving xx different patients.This is the first of two reports.Refer to 9611594-2026-00378 for the second report.It was reported that a bubble formed in the nasogastric tube.It was noted when attempting to unclog/flush the tube.It was replaced.

• Brand Name: CORTRAK 2 NG/NI FEEDING TUBE ELECTROMAGNETIC TRANSMITTING STYLET WITH ENFIT
• 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 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25332510
• Report Number: 9611594-2026-00377
• Device Sequence Number: 18612165
• Product Code: KNT
• UDI-Device Identifier: 00350770460536
• UDI-Public: (01)00350770460536
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 40-9551TRAK2
• Device Catalogue Number: 40-9551TRAK2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• 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: 06/17/2024
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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