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); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidents, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 9611594-2026-00475 for the second report.It was reported that a nasogastric feeding tube clogged, and in turn burst when they tried to unclog it.It was removed intact.No injury to the patient.
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.Below the y-port connector, a hole/ splitting was observed.There are also signs of discoloration on the outer portion of tubing.The tube was flushed through the y connector (proximal end) and was unable to flush completely due to the hole/ split on the tubing just below the y-port connector.At the area just below the y-port connector, an opening of tubing portion was seen.The tubing appeared to burst axially causing for tube to not function as intended.When feeling the tubing further down, at 100cm marking, hardened feeling was felt on this area.The tubing was cut and opened to inspect the inner surface of tubing walls.From 100cm marking until 95cm marking hard, log light brownish material was stuck in the tube.The root cause has been determined to be use error.All information reasonably known as of 18 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as (b)(4).This information is submitted pursuant to 21 cfr 803, 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 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: 25552592
• Report Number: 9611594-2026-00474
• Device Sequence Number: 18826727
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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
• 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: 02/13/2025
• 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: 02/06/2025
• Initial Report FDA Received Date: 06/18/2026
• 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