MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	51-4602
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initially deemed not reportable based on our reporting strategy active at the time of the alert date; however, following a recent retrospective review of complaints this event was made reportable out of an abundance of caution.The device history record for lot 30305072 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Feeding was simulated using water mixed with food grade dye.A 35ml enfit syringe was attached to the central port, with the side port closed.The water was infused.There was no resistance.It exited the bolus tip.The process was repeated with the syringe attached to the side port, with the central port closed.Again, the water flowed without resistance and exited the bolus tip.The complaint is not confirmed based on sample evaluation.No problem was detected.All information reasonably known as of 20 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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 that a nasogastric tube could not be advanced over the guidewire because resistance was encountered due to a hard piece.

• Brand Name: CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE 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: 24932377
• Report Number: 9611594-2026-00237
• Device Sequence Number: 5357303
• Product Code: KNT
• UDI-Device Identifier: 00350770462301
• UDI-Public: (01)00350770462301(240)104623002(17)271010(10)30305072
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 51-4602
• Device Catalogue Number: 51-4602
• Device Lot Number: 30305072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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
• Patient Sex: Unknown