MAUDE Adverse Event Report: Avanos Medical Inc. NEOMED Nasogastric/Orogastric Feeding Tubes; Tube, Nasogastric

Model Number	FTS5.0P-NC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.A device history record review could not be performed because the lot number and complete udi-pi were not provided.Root cause could not be determined.All information reasonably known as of 21 sep 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.
Event or Problem Description
It was reported that while the device was in use, staff responded to patient monitors alerting to desaturation.When aspiration through the orogastric feeding tube was attempted, substantial amounts of air and little to no gastric contents were obtained.Upon reconnecting the feeding tube to the enteral extension tubing, patient feeding solution was observed leaking at the connection between the tubing and the connection hub.No patient harm was reported.

• Brand Name: NEOMED Nasogastric/Orogastric Feeding Tubes
• Common Device Name: Tube, Nasogastric
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Ningbo Tianyi Medical Appliance CO., Ltd; no.788,mozhi north rd; tourism resort, dongqian lake; ningbo zhejiang, cn 31512 1; CH 315121
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50852752
• Report Number: 3011270181-2026-00181
• Device Sequence Number: 10026276
• Product Code: BSS
• UDI-Device Identifier: 00350770000572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FTS5.0P-NC
• Device Catalogue Number: FTS5.0P-NC
• Device Lot Number: Unknown
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown