MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SYRINGE, 10ML SALINE IN 10ML

Catalog Number	EMZ111240H
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "contaminated item" and "syringe looks to have dirt like substance.".
Additional Manufacturer Narrative
The customer reported a contaminated item and that the syringe looks to have dirt like substance; according to the customer, there was particulate on the syringe handle inside the package, with no patient impact.The batch record was reviewed and all considered acceptance criteria were met; a review of 240 syringe retains was performed and zero syringes were found containing a brown stain on the plunger of the syringe outside of the fluid-path.It was confirmed that the particulate is in the plunger of the syringe (outside of the sterile fluid-path), and the low filled syringes and syringes with missing tip caps exiting the filler room were determined to be the most likely root cause causing saline spillage onto the sterilizer trays and in the sterilizer.The piston component of the plunger of the syringe provides a seal in the internal diameter of the barrel, which keeps the sodium chloride protected within the fluid path, and no medical intervention, serious injury, or follow-up care has been reported.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854898
• Report Number: 1417592-2026-47607
• Device Sequence Number: 21220914
• Product Code: NGT
• UDI-Device Identifier: 30888277675814
• UDI-Public: 30888277675814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Catalogue Number: EMZ111240H
• Device Lot Number: 24AJA065
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 09/22/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown