MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	40-7431
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Corflow ng tubing with guidewire stylets left post ng placement.Procedure is to place the tube using the guidewire, send patients to x-ray to confirm placement, then remove stylet before using the tube.The tube was utilized for feedings/meds for several days before realizing the guidewire remained.Because the stylet and the ports are the same color, nursing was not alerted to the fact that the stylet had not been removed post imaging.Design flaw.

• Brand Name: AVANOS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 24698414
• Report Number: 24698414
• Device Sequence Number: 21376576
• Product Code: KNT
• UDI-Device Identifier: 00350770460321
• UDI-Public: (01)00350770460321
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2030
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026
• Report Date (Section F): 03/03/2026

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
• Device Model Number: 40-7431
• Device Catalogue Number: 40-7431
• Device Lot Number: 20136433
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/03/2026