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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe caps that come in package do not stay on syringe.Appears that caps are not threaded, so they just pop right off, thus not protecting enteral feeding contents.These have been found over multiple days/shifts over the past week and a half.There is a wide variety of lot numbers affected, but not all syringe caps in each lot are faulty.Only 60 ml syringes appear to be affected.([redacted] lot# ty250712.But again, have seen this issue with several lot numbers: ty250712, ty250802, ty250809, ty250725, ty250801).

• 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: 24277913
• Report Number: 24277913
• Device Sequence Number: 9963033
• Product Code: PNR
• UDI-Device Identifier: 00350770001173
• UDI-Public: (01)00350770001173(240)120001643(17)280711(10)TY250712
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/27/2026
• Report Date (Section F): 01/27/2026

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: PNM-S60NC
• Device Catalogue Number: PNM-S60NC
• Device Lot Number: TY250712, TY250712, TY250802
• 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: 02/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/27/2026