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

Model Number	40-9368
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the nasogastric (ng) tube was placed and "confirmed via kub.Nurse evaluated ng tube and noted leaking from ng line near the hub of the ng tube.Ng had to be pulled and replaced." there was no reported injury.Additional information received 28-may-2026 stating "the tube was only in place for a few hours, no oil-based products, only feeds.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 30353551, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One corflo tube was received with the product packaging.The associated stylet was not returned.After cleaning decontamination, the sample was examined in a well-lit area.It appeared generally in clean condition.The 2-port enfit connector was attached at the proximal end of the tubing.The connector did not exhibit visible damage.The connection appeared to be secure.The outside of the tubing did not exhibit discoloration.The bolus tip was attached at the distal end of the tubing.Damage was observed just below the base of the enfit connector.The damaged area was examined under magnification.A grouping of jagged tears was observed in the tubing, near the connector.The tears were on varying sides of the tubing.They were located from just below the base of the connector to approximately 1cm below the base.The tube was cut laterally, just below the base of the connector.Then, on the opposite wall from the tears, the tubing was cut axially, in order to view the inner wall.The inner wall of the tubing exhibited similar tearing and surface abrasions or erosion.Root cause could not be determined.All information reasonably known as of 15-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 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24903765
• Report Number: 9611594-2026-00187
• Device Sequence Number: 21288911
• Product Code: KNT
• UDI-Device Identifier: 10350770460434
• UDI-Public: (01)10350770460434(240)104604302(17)300113(10)30353551
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare 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: 40-9368
• Device Catalogue Number: 40-9368
• Device Lot Number: 30353551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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 Age: 19 MO
• Patient Sex: Male
• Patient Weight: 8 KG