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

Model Number	42-9225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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; therefore, the udi-pi is unavailable.The lot number was not provided by the customer.All information reasonably known as of 12-may-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.
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 first of two reports.Refer to 9611594-2026-00316 for the second event.It was reported vai fda medwatch / fda user facility report mw report 22736670 the following [event 1]: since [date redacted] into [date redacted] - a period of approximately 2 months, the cicu [coronary intensive care unit] and [redacted]hematology-oncology departments have noted 4 incidents involving the 5fr corpak feeding tubes.No patient harm or injury sustained by any of the patients involved.Issues include feeding tube noted to be transected on chest x-ray on a [age redacted] old pt.The provider came to bed side and feeding tube removed with 10 cm retained by pt.Occurred with [age redacted] patient.When removing pts ng [nasogastric] tube (placed estimated 2 months ago) rn gently removed tube (no resistance was met) and upon removal the tube broke in half.Pt tolerated removal well.Rn confirmed tip of ng tube was present at removal, and that concern is ng tube was very fragile and if it would have broken off while still placed in pt.Concern is that this could have resulted in multiple serious events occur (aspiration while sleeping with tube feeds and or bowl obstruction).

• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25155014
• Report Number: 9611594-2026-00312
• Device Sequence Number: 13447966
• Product Code: KNT
• UDI-Device Identifier: 00350770460857
• UDI-Public: (01)00350770460857
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 42-9225
• Device Catalogue Number: 42-9225
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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