MAUDE Adverse Event Report: AVANOS MEDICAL INC. NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES; DH NASOGASTRIC FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	PFTS5.0P-NC
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	05/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The sample is reported to be available but has not yet been received by the manufacturer.All information reasonably known as of 08 jun 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
The customer reported that a nasogastric feeding tube broke during use.The patient reportedly began vomiting, developed bradycardia and oxygen desaturation, and the feeding tube was observed protruding from the mouth.The securement device remained in place and the broken portion of the tube was removed.Additional information reported that the tube physically snapped at approximately the 26-centimeter marking.No patient injury or medical intervention was reported.Additional information received on may 26, 2026, reported that the tube physically snapped at the proximal end where the syringe connects.

• Brand Name: NEOMED NASOGASTRIC/OROGASTRIC FEEDING TUBES
• Common Device Name: DH NASOGASTRIC FEEDING TUBES (NEOMED AND NEOCONNECT)
• 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 ; 4704485487
• MDR Report Key: 25443305
• Report Number: 3011270181-2026-00083
• Device Sequence Number: 5938789
• Product Code: FPD
• UDI-Device Identifier: 00350770001753
• UDI-Public: (01)00350770001753
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: PFTS5.0P-NC
• Device Catalogue Number: PFTS5.0P-NC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 05/12/2026
• Initial Report FDA Received Date: 06/09/2026
• 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
• Patient Sex: Male