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

Model Number	40-9228
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 30351258, 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 07-aug-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 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.
Event or Problem Description
It was reported the nasogastric "(ng) [tube} on patient was blocked, rn's [registered nurses] were attempting to unblock ng.Ng was able to be unblocked but patient went unresponsive immediately after.Code blue was called.Approximately 45-minutes of code was run.Upon arrival to picu [pediatric intensive care unit] post code, x-ray was done and ng was shown to be defectiveing was removed from patient, it was noted to have a defect." the device was originally inserted on (b)(6) and removed on (b)(6) during the critical incident.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30351258, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Root cause could not be determined.The subject sample was returned and evaluated confirming a ballooning area with an axial split located approximately 10cm above the bolus tip.When palpating the tubing further down, at the 8cm marking, a hardened feeling was felt on this area.The tubing was cut and opened to inspect the inner surface of tubing walls.From the 8cm marking until bolus end tip, whitish powdery substance residues were stuck in the tube.The root cause of the reported issue seems to be a user related problem since as per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 26-nov-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 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: CORFLON NG/NI FEEDING TUBE WITH STYLET, 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: 22744131
• Report Number: 9611594-2025-00176
• Device Sequence Number: 17971515
• Product Code: KNT
• UDI-Device Identifier: 00350770460390
• UDI-Public: (01)00350770460390(24)104603902(17)291202(10)30351258
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-9228
• Device Catalogue Number: 40-9228
• Device Lot Number: 30351258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 3 KG