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

Model Number	20-9551
Medical Device Problem Codes	Break (1069); Complete Blockage (1094)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 30-mar-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
It was reported there was an "incident where a cortrak tube was clogged and in the unclogging process the tube broke, resulting in a large section of retained tube that required an [esophagogastroduodenoscopy] egd for retrieval.There was no reported injury.
Additional Manufacturer Narrative
Additional information: a2, a3a, a4, and b5.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 21 cfr 803, 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
Additional information received 20-mar-2026 stated the solution used to unclog the tube was water and unc declogging kit (pancrealipase/sodium bicarbonate).The tube was used for continuous feedings 90 ml/hr.The feeding solution was pivot 1.5.It was unclear if the device was used for oral and crushed medications.Because the patient also had nasogastric (ng)-salem sump device.It is not believed the device was used to suction as there was no documented output.The ng salem sump was kept for medication administration.There were no oils or oil-based medications used in the device.No mct oil was used in the tube.The device was flushed with 100 ml water by pump every 2-hours.The typical syringe used on the device was 60 ml.

• Brand Name: CORFLO NG/NI FEEDING TUBE WITH STYLET
• 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: 24743468
• Report Number: 9611594-2026-00165
• Device Sequence Number: 8779904
• Product Code: KNT
• UDI-Device Identifier: 00350770458137
• UDI-Public: (01)00350770458137
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 20-9551
• Device Catalogue Number: 20-9551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 67 KG