MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO FEEDING TUBE WITH 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)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 26-mar-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
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the first of two reports.Refer to 9611594-2025-00068 for the second event.It was reported the wire was protruding from the distal end of the tube." the wire was not protruding at the time of flushing, prior to insertion.It became evident when the tube was removed due to issues in the pharynx." additional information received 25-mar-2025 stating the "patient felt discomfort when tube passed into pharynx." the patient had a strong gag reflex.There was no reported medical intervention.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30303738, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was received with an opened original pouch packaging.The stylet guidewire was returned inside the yellow tubing.No other components were returned.When checking the overall appearance of the tube with the stylet wire inside, there were multiple curvature observed.The two components were then separated for inspection and examination.The 55" stylet wire was checked and placed beside the 8fr ng [nasogastric] tubing.Since the stylet wire was noticed to have a slight curvature, it was difficult to determine if there are any mismatch of the length between stylet wire and yellow tube.The ng tubing was relaxed and taped at the lab table prior to insertion of wire to fully advance without coiling.The 55" stylet was then inserted into the 8fr ng tube.There was no resistance felt throughout the passage through ng tube.When the stylet wire entered the distal end of the device, the tip of the stylet went through the bolus plug window and stopped advancing when the stylet cap bottomed against the ng tube y- connector.This was evidence that the stylet wire protruded.Root cause could not be determined.All information reasonably known as of 02-jul-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.

• Brand Name: CORFLO FEEDING TUBE WITH 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: 21701832
• Report Number: 9611594-2025-00067
• Device Sequence Number: 7696008
• Product Code: KNT
• UDI-Device Identifier: 00350770460833
• UDI-Public: (01)00350770460833(240)104608302(17)271010(10)30303738
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 30303738
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG