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

Model Number	42-9368
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	12/30/2025
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 30 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 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
Avanos medical inc.Received a single report that referenced two different incidents, which were associated with separate units.This is the second of two reports.Refer to 9611594-2026-00034 for the first report it was reported, an nasogastric (ng) tube was found to be leaking.Upon return of the ng aspirate, a leak was observed within the patient¿s nostril, approximately 2 cm inward from the tube holder.The location of the split suggests it is unlikely to have been caused by handling.The tube had been in situ for only 24 hours, and the patient was too clinically unstable to mobilize or reposition in bed.Per additional information received on 13jan2026, the patient was receiving continuous feedings through the ng tube.No blended feeds or thick-consistency formulas were administered.The tube may have been used for oral and/or crushed medications.The tube was flushed each time medications or feedings were administered; the tube had been in place for only four hours.A 20 ml or 50 ml syringe was used for flushing.There was no history of clogging prior to the rupture.Flushing was performed manually using a syringe.A 20 ml or 50 ml syringe was used for manual flushing.Pump use was not applicable.Warm solution was used for any attempted unclogging.

• Brand Name: CORFLO NG/NI FEEDING 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: 24259123
• Report Number: 9611594-2026-00035
• Device Sequence Number: 9600525
• Product Code: KNT
• UDI-Device Identifier: 00350770460925
• UDI-Public: (01)00350770460925(240)104609202(17)280103(10)30352216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care 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: Health Professional
• Device Model Number: 42-9368
• Device Catalogue Number: 42-9368
• Device Lot Number: 30352216
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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