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

Model Number	42-9438
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire of the nasogastric tube is showing through the tip.Normally it stops before the tip.No injuries or medical intervention.
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 30248508 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Upon receipt of the device, the stylet guidewire was still inserted inside the yellow tubing.Prior to decontamination, the stylet guidewire was tried to remove from the yellow tubing and was removed without resistance.No need to activate an internal lubricant by flushing the tube on the side port with liquid.After decontamination, the entirety of the tubing was inspected.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 observed the tip of the stylet guidewire went through the bolus plug window.The two components (stylet guidewire and yellow tubing) were separated and allow to both relaxed on the lab table.The stylet guidewire appeared to have some bending in multiple locations (near the purple hub and body).When the stylet guidewire was re-inserted back into the yellow tubing.The stylet tip went through the bolus plug window again and then stopped advancing when the stylet hub bottomed against the yellow tube y-connector port.The complaint is confirmed based on sample evaluation.The root cause has been determined to be inadequate procedures, working instructions and equipment during the manufacturing process.All information reasonably known as of 04 may 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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL 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 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25071716
• Report Number: 9611594-2026-00267
• Device Sequence Number: 13445648
• Product Code: KNT
• UDI-Device Identifier: 10350770460960
• UDI-Public: (01)10350770460960(240)104609602(17)280313(10)30249508
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K821906
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 42-9438
• Device Catalogue Number: 42-9438
• Device Lot Number: 30248508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• 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: 04/28/2024
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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