MAUDE Adverse Event Report: AVANOS MEDICAL, INC. PU FEEDING TUBE; TUBE, NASOGASTRIC

Model Number	FTM5.0P-EO, FTM6.5P-EO, FTM8.0P-EO
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The avanos polyurethane neonatal feeding tubes were suspected to be associated with three neonatal esophageal perforations during insertion.Orogastric tube placement attempted with resistance met.Attempted to place with smaller orogastric tube with resistance again met.

• Brand Name: PU FEEDING TUBE
• Common Device Name: TUBE, NASOGASTRIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 20722752
• Report Number: 20722752
• Device Sequence Number: 6639569
• Product Code: BSS
• UDI-Device Identifier: 00350770002217
• UDI-Public: (01)00350770002217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2024
• Report Date (Section F): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FTM5.0P-EO, FTM6.5P-EO, FTM8.0P-EO
• Device Catalogue Number: FTM5.0P-EO
• Device Lot Number: TY220305 AND TY231214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/18/2024