MAUDE Adverse Event Report: Avanos Medical Inc. ENFit PU Feeding Tube Purple; DH Nasogastric (NG) Feeding Tubes (NeoMed and NeoConnect)

Model Number	PFTM6.5P-NC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction

• Brand Name: ENFit PU Feeding Tube Purple
• 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, cn 31512 1; CH 315121
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50085855
• Report Number: 3011270181-2026-00143
• Device Sequence Number: 21333600
• Product Code: FPD
• UDI-Device Identifier: 00350770001791
• UDI-Public: (01)00350770001791(240)120001688(17)250716(10)TY220717
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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 Expiration Date: 07/16/2025
• Device Model Number: PFTM6.5P-NC
• Device Catalogue Number: PFTM6.5P-NC
• Device Lot Number: TY220717
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2025
• 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: 06/03/2025
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown