MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number	PFTM6.5P-NC
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record for the provided is in-progress.All information reasonably known as of 11-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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.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 via fda medwatch / fda user facility report mw report mw5176288 the following: "on (b)(6) 2025: infant had a 6.5 french orogastric tube neomed feeding tube with enfit connector.When attempting to auscultate it was noted that air and residual feeding was coming out of tube at the 18cm mark on tube.Tube was removed and noted to be split at the 18 centimeters mark.Tube was inserted on (b)(6) 2025 and secured at 16cm.Unknown how the split occurred.".

• Brand Name: ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM
• Common Device Name: DH NASOGASTRIC (NG) 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 31512 1
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 25143176
• Report Number: 3011270181-2026-00067
• Device Sequence Number: 21163469
• Product Code: FPD
• UDI-Device Identifier: 00350770001791
• UDI-Public: (01)00350770001791(240)120006592(11)250909(17)280908(10)TY250909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/11/2026

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: PFTM6.5P-NC
• Device Catalogue Number: PFTM6.5P-NC
• Device Lot Number: TY250308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 08/11/2026
• 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 Age: 1 MO
• Patient Sex: Male