MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 60ML ENFIT SYRINGE, CLEAR

Catalog Number	NON66060
Medical Device Problem Codes	Leak/Splash (1354); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the "purple plunger sticks and then all of a sudden gush shoving more fluid into pts tummy" and "plunger comes off in the tube making it very difficult to continue without leaking.".
Additional Manufacturer Narrative
According to the facility, the "purple plunger sticks and then all of a sudden gush shoving more fluid into pts tummy" and "plunger comes off in the tube making it very difficult to continue without leaking." per the facility, the syringe is "used for enteral care." no reported serious injuries or medical interventions.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: 60ML ENFIT SYRINGE, CLEAR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield 60093
• MDR Report Key: 22973773
• Report Number: 1417592-2025-00445
• Device Sequence Number: 18484416
• Product Code: PNR
• UDI-Device Identifier: 10888277703650
• UDI-Public: 10888277703650
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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 Catalogue Number: NON66060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 45 KG