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

Model Number	40-9366
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record for the provided is in-progress.All information reasonably known as of 13-may-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 there was an issue with a 6fr avanos ngt (nasogastric) where the distal end/gastric tip of the ngt (opening into the stomach) was completely closed over (no hole formed during manufacturing) which meant that after insertion the ngt was unable to be flushed or aspirated.Additional information received 15-apr-2026 stated "unfortunately the issue was found post tube insertion.Initially noticed difficulty trying to remove the stylet despite pre-flushing with water, then were unable obtain a gastric aspirate to confirm tube position.Noted resistance "[increasingly]" when trying to obtain a gastric aspirate.A decision was made to remove the ngt as it was assumed to be faulty and then we inserted a new one for the patient.Upon removal, it was noticed the ngt was unable to be flushed with water and that¿s when we noticed there was no opening formed at the distal end/gastric tip of the ngt.The user "examined the rest of our tube stock and found one other ngt that had a partially formed opening (from the same batch number)." 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 25165125
• Report Number: 9611594-2026-00324
• Device Sequence Number: 16002405
• Product Code: KNT
• UDI-Device Identifier: 10350770460427
• UDI-Public: (01)10350770460427(240)104604202(17)300210(10)30356075
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: 40-9366
• Device Catalogue Number: 40-9366
• Device Lot Number: 30356075
• Date Returned to Manufacturer: 05/04/2026
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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 Sex: Unknown