MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP-NAMIC MEDLINE; SYRINGE,1ML,WHITE,L/L,PC

Catalog Number	DYNJSYRPC01W
Medical Device Problem Codes	Contamination (1120); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2025, they were finding a lot of particulate inside the syringes.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, they were finding a lot of particulate inside the syringes.There was no patient involvement, they failed visual inspection.No additional information at this time.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.
Additional Manufacturer Narrative
Updated/corrected b5: description of problem.Updated h6: medical device problem code.Updated h7: component code.This was initially reported due to "particulate in syringes" however it was clarified that the particulate was found on or in the packaging of the syringe, not in the syringe itself.
Event or Problem Description
Facility initially stated they were finding a lot of particulate inside the syringes, however the rep clarified that the particulate was found on the packaging of the syringes, not the syringes themselves.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,1ML,WHITE,L/L,PC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP-NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 24057443
• Report Number: 3015910259-2026-00008
• Device Sequence Number: 21296133
• Product Code: FMF
• UDI-Device Identifier: 10888277948488
• UDI-Public: 10888277948488
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K103736
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Catalogue Number: DYNJSYRPC01W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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 Sex: Unknown