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

Model Number	42-9558TRAK2
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available but has not been returned for evaluation.A review of the device history record and udi number are in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 21-may-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 "nutrition nurse inserted cortrak tube into the bowel, removed stylet and then re-inserted tube for a re-trace which is standard practice when using cortrak at this trust.She felt some resistance on re-insertion ¿ ¿we¿ve unfortunately had an issue today with an njt [naso-jejunal tube] being perforated by the stylet.The tube was placed what was thought to be successfully, the wire was removed with no stiffness at all but when the wire was placed back into the tube to get the final trace, there was a slight bit of resistance, with slight pressure, the wire then passed easily.The trace showed that the tube was kinked so it was withdrawn into the oesophagus and the tube passed with ease.However, the patient started complaint of pain and a burning sensation, so we removed the tube and the njt had been perforated by the wire." there was no reported injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30327097, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.An opened original pouch packaging was returned with the sample.The stylet guidewire was returned inside the yellow tubing.The sample was then disinfected.During evaluation, a portion of stylet guidewire tip was seen protruding just between 20cm and 19cm underneath.When viewed under magnification (20x), there was a hole/ punctured observed on the area described earlier.The stylet guidewire was completely detached or removed from the yellow tubing and exhibited bending, kinking in multiple areas.Root cause could not be determined.All information reasonably known as of 08-jul-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.

• Brand Name: CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC TRANSMIT STYLET, 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22081888
• Report Number: 9611594-2025-00108
• Device Sequence Number: 12729295
• Product Code: KNT
• UDI-Device Identifier: 00350770461007
• UDI-Public: (01)00350770461007(240)120006320(17)280103(10)30327097
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 42-9558TRAK2
• Device Catalogue Number: 42-9558TRAK2
• Device Lot Number: 30327097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORTRAK
• Patient Age: 34 YR
• Patient Sex: Female