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

Model Number	42-7361
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was inserted (b)(6) 2025 and sutured in place by the.Plastic surgery team." on [(b)(6) 2025] resistance to flushing worsened during the day and attempts were made to unblock with various size syringes.The nurse recorded "some contents returning via nose and mouth, so decision made to remove ngt (nasogastric tube) same done and obvious fracture in tubing just past suture mark when examined post removal." there was no reported injury.
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned when this report was filed.A review of the device history record and udi number are in-progress.All information reasonably known as of 14-jan-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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.All information reasonably known as of 18-feb-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30356582, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The subject sample provided was evaluated confirming at the 46cm marked location, the tubing appeared to have expanded to form a slight balloon shape which burst axially causing an opening on the tube.The tube was felt towards the distal end.At 30cm marking, hardened feeling was felt.The tubing was cut and opened to inspect the inner surface of tubing walls.From 30cm marking until bolus end tip, light brownish/ yellowish substance residues located in multiple areas of the tubing were stuck and dried up it became crusty.The root cause of the reported issue seems to be a user related problem as per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 01-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 (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 FEEDING 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: 24082997
• Report Number: 9611594-2026-00012
• Device Sequence Number: 5816270
• Product Code: KNT
• UDI-Device Identifier: 00350770460802
• UDI-Public: (01)00350770460802(240)104608002(17)280103(10)30356582
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 42-7361
• Device Catalogue Number: 42-7361
• Device Lot Number: 30356582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 03/18/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/19/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 49 KG