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

Catalog Number	EMZE010001Z
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the problem is; once the syringe is primed, the plunger still sticks.Which causes the physician to apply too much pressure to force the saline out when rinsing the eye after injections.".
Additional Manufacturer Narrative
The customer reported ¿high injection force¿ and that, ¿once the syringe is primed, the plunger still sticks,¿ which causes the physician to apply too much pressure to force the saline out when rinsing the eye after injections.The investigation reviewed manufacturing records and incoming records, and (9) customer returned samples and (35) random retention samples were sent for piston break force bond test and inject and aspiration force test; testing completed successfully with no negative trends or outlying data points.Based on the results of the investigation, the reported complaint could not be confirmed, and the testing showed that syringe performance for breaking the piston/barrel sterilization seal and moving the plunger to expel saline are within the desired criterias.The most probable root cause for the customer¿s complaint is believed to be the need for further training on the use of medline syringes per ifu, and the most likely conclusion is that further clinical education is recommended in the use of medline flush syringes per the ifu.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: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945213
• Report Number: 1417592-2026-54037
• Device Sequence Number: 13369283
• Product Code: NGT
• UDI-Device Identifier: 00363807100015
• UDI-Public: 00363807100015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/28/2026

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: EMZE010001Z
• Device Lot Number: 3144929
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2025
• 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: 03/12/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown