MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES; DH CPK NG TUBES

Model Number	40-9226
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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.The device history record for lot 30352226 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The returned sample device was examined and infused with water showing that the tubing had signs of damages (tear/hole).A root cause could not be determined.All information reasonably known as of 21 jan 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 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving the same patient.This is the first of three reports.Refer to 9611594-2026-00017 for the second report; refer to 9611594-2026-00018 for the third report.It was reported, ¿what we are experiencing is the stylet not be able to be removed easily kinking the ng tube in the pats stomach.There have been holes noted near the end of tube enfit section where we aspirate fluid to do ph for proper placement.Unable to get aspirate and then noted the tube had holes." per additional information received on 13nov2025, "no injury or additional intervention took place aside from tube replacement.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES
• Common Device Name: DH CPK NG TUBES
• 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: 24148677
• Report Number: 9611594-2026-00016
• Device Sequence Number: 8887398
• Product Code: KNT
• UDI-Device Identifier: 00350770460383
• UDI-Public: (01)00350770460383(240)104603802(17)291216(10)30352226
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 40-9226
• Device Catalogue Number: 40-9226
• Device Lot Number: 30352226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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
• Patient Sex: Unknown