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

Model Number	FTL8.0V-NC
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: ENFit PVC Feeding Tube Orange
• 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: 50006283
• Report Number: 3011270181-2026-00111
• Device Sequence Number: 16048012
• Product Code: FPD
• UDI-Device Identifier: 00350770001029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120182
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 07/31/2026
• Device Model Number: FTL8.0V-NC
• Device Catalogue Number: FTL8.0V-NC
• Device Lot Number: TY230731
• 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: 07/17/2024
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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