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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504); Obstruction of Flow (2423)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record and udi are in-progress.All information reasonably known as of 16 oct 2024 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 complaint comp (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, "there has been an incident lately with one of your products, nj [nasojejunal] tube 10fr 140cm.Nj tube broke off / snapped on the (b)(6) 2024.After returning from theatre i planned in removing the nj tube as per plan because it was handed over that it was blocked.Also, the medical team was aware of it and advised to remove it.When i removed the nj, i noticed that part of it was missing (it snapped at 62cm and approximately 57cm remained inside).I called the spr [specialist registrar] on duty and immediately informed them about what happened.Advised to keep the patient nbm [nothing by mouth] and wait for the x-ray to confirm the position of the tube (the one left inside).The medical team will contact the gastro-team for advice to manage this issue.X-ray has been done and tip of nj tube is visible in stomach.Gastro came to review and did a retrieval of nj tube remnant (removed endoscopically) on the (b)(6) 2024.The nj tube remnant was found to have a hole and somewhat torn.¿ per additional information received on 26sep2024, the patient did not sustain any injuries and is stable.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30253137, 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 16-oct-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 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 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE
• 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: 20465958
• Report Number: 9611594-2024-00213
• Device Sequence Number: 12569714
• Product Code: KNT
• UDI-Device Identifier: 00350770460987
• UDI-Public: (01)00350770460987(240)120004773(17)280410(10)30253137
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: N/A
• Device Catalogue Number: 42-9551TRAK2
• Device Lot Number: 30253137
• Was Device Available for Evaluation?: Yes
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG