MAUDE Adverse Event Report: Avanos Medical, Inc. ENFit Syringe; Enteral Syringes with enteral specific connectors

Model Number	NM-S60NC
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Unopened syringe package found to have what appears to be a dark colored hair or fiber inside the syringe.

• Brand Name: ENFit Syringe
• Common Device Name: Enteral Syringes with enteral specific connectors
• Manufacturer (Section D): Avanos Medical, Inc.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 50752729
• Report Number: 50752729
• Device Sequence Number: 15806325
• Product Code: PNR
• UDI-Device Identifier: 00350770001166
• UDI-Public: (01)00350770001166
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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
• Device Model Number: NM-S60NC
• Device Catalogue Number: NM-S60NC
• Device Lot Number: TK250607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/04/2026