MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ENFIT SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	PNM-S60NC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Cap for 60ml enteral feeding syringe does not stay on.

• 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: 25215832
• Report Number: 25215832
• Device Sequence Number: 9997966
• Product Code: PNR
• UDI-Device Identifier: 00350770001173
• UDI-Public: (01)00350770001173
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/12/2026
• Report Date (Section F): 05/12/2026

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: PNM-S60NC
• Device Catalogue Number: PNM-S60NC
• 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: 05/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2026
• 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: 05/12/2026