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

Model Number	42-9226
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sample device was examined and infused with water showing that the tubing had signs of damages (tear/hole).There were external dent marks identified after the sample was inspected under magnification just below the y-connector.The area was where the uneven surface appeared jagged and/or wrinkled.The tubing was cut to view the inside surface of the tubing.Once the tubing was opened and viewed under magnification, there were lines and indentations in the inner walls of the tubing.Per customer comments, the user did not lubricate the tube with water during removing stylet.The instructions for use (ifu) stated that related to tubes packaged with a stylet the following: after tube position in the stomach is confirmed, remove stylet by flushing tube through the side port with up to 10 ml of water to activate internal lubricant immediately prior to stylet removal.Warning: never reinsert stylet when tube is in patient.The use cause was use related.All information reasonably known as of 14-apr2026 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 halyard health 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 halyard health.Halyard health 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 halyard health 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 a halyard health product is defective or caused serious injury.
Event or Problem Description
I was reported there was a tear on the nasogastric tube."it was reported that a user did not lubricate the tube with water during removing stylet." there was no reported injury.

• Brand Name: CORFLO NG/NI FEED 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 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24896450
• Report Number: 9611594-2026-00212
• Device Sequence Number: 15614883
• Product Code: KNT
• UDI-Device Identifier: 10680651460865
• UDI-Public: (01)10680651460865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 42-9226
• Device Catalogue Number: 42-9226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/11/2024
• Initial Report FDA Received Date: 04/16/2026
• 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