MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERNAL ACCESS DEVICE; DH CORTRAK DISPOSABLES

Model Number	40-9438TRAK2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fda maude adverse event report mdr report key 21813548, "nurse reported that patient could taste his medications this am [morning], which were administered via small bore ngt [nasogastric tube].Repeat cxr [chest x-ray] confirmed tube placement.Rd [registered dietitian] noted coil on x-ray and concern for compromised integrity of tube.Rd pulled old tube, and it was broken at the 64cm mark with noted ballooning at broken part.Gi [gastrointestinal] was consulted, xr [x-rays] were ordered, pt (patient) underwent egd [esophagogastroduodenoscopy] for removal of broken piece retained in stomach.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.A root cause could not be determined.Https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfmaude/detail.Cfm?mdrfoi__id=21813548&pc=knt.All information reasonably known as of 17 feb 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 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 ENTERNAL ACCESS DEVICE
• 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: 24367367
• Report Number: 9611594-2026-00063
• Device Sequence Number: 5381286
• Product Code: KNT
• UDI-Device Identifier: 00350770460512
• UDI-Public: (01)00350770460512
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/17/2026

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: 40-9438TRAK2
• Device Catalogue Number: 40-9438TRAK2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG