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

Model Number	42-7558
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced five different incidences, which were associated with separate units, involving five different events.This is the second of five reports.Refer to 9611594-2025-00263 for the first event.Refer to 9611594-2025-00265 for the third event.Refer to 9611594-2025-00266 for the fourth event.Refer to 9611594-2025-00267 for the fifth event.It was reported the nasojejeunal (nj) tube was guidewire was noticed to be intermittently protruding when the tube was inside the patient.Unknown if injury occurred.Additional information received 22-oct-2025 stated "on flushing tube prior to insertion the guide wire protruded outside of the side feeding hole by 1-2mm.
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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 06-nov-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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.All information reasonably known as of 31-dec-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30356064, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The subject sample provided was evaluated confirming the stylet guidewire purple hub was seen engaged into the 2-port y-connector securely.At the same manner, the distal bolus end of the tube was inspected and did not observe the tip of the stylet guidewire went through the bolus plug window.When the stylet guidewire was re-inserted back into the yellow tubing, an appearance of stylet tip was visible through the bolus plug window.Root cause could not be determined.All information reasonably known as of 12-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 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.

• Brand Name: CORFLO NG/NI FEEDING TUBE, STYLET 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23503613
• Report Number: 9611594-2025-00264
• Device Sequence Number: 15730013
• Product Code: KNT
• UDI-Device Identifier: 00350770460833
• UDI-Public: (01)00350770460833(240)104608302(17)280103(10)30356064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 42-7558
• Device Catalogue Number: 42-7558
• Device Lot Number: 30356064
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 02/11/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/31/2025; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2025
• 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