MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI FEED TUBE WITH STYLET WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	40-9432
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.It was reported the corflo ngt has a hole in tubing and y-adapter coming off.The tube was placed (b)(6) 2026, and i had to pull it on the (b)(6) 2026 as the patient could instantly taste feeds and meds with less than a 3ml flush and it was causing aspiration.When pulled the clinician found a hole in it.The clinician reports following protocol from public hospital dietitian which is max replacement time of 90-days.Once she throws it up its replaced with a new device.The device is flushed every 3-hours while on feeds with a minimum 60mls water, something is "run" every day.The device is flushed with 30mls water before and after medications.All medications are crushed finally and dispersed in the proper amount of water according to the pharmacy.There were no reported injuries.The medical treatment was tube replacement.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30345668, in this complaint was reviewed, and the material was produced according to the manufacturing procedures and met the quality requirements.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.Root cause could not be determined.All information reasonably known as of 22-apr-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 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: CORFLO NG/NI FEED TUBE WITH STYLET WITH ENFIT CONNECTOR
• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24958618
• Report Number: 9611594-2026-00250
• Device Sequence Number: 9890419
• Product Code: KNT
• UDI-Device Identifier: 10350770460489
• UDI-Public: (01)10350770460489(240)104604802(17)291001(10)30345668
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: Lay User/Patient
• Device Model Number: 40-9432
• Device Catalogue Number: 40-9432
• Device Lot Number: 30345668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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 Sex: Female