MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SYRINGE 3ML L/L PC RED

Catalog Number	DYNJSYRPC3R
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer (b)(6) is having issues with this dynjsyrpc3r syringe in that the plunger keeps coming back out of the syringes during use.
Additional Manufacturer Narrative
Customer reported that the syringe plunger keeps coming back out of the syringes during use, and two videos were received from the customer showing the 3ml syringe malfunctioning during surgery.A review of the device history records was performed for the indicated packaging and component lots and confirmed that the lots met all material, assembly and performance specifications; the pack production record was reviewed with no line down situations, deviations, or non-conformances, and the unopened pouch was visually inspected as received with no visible damage or defects noted.The customer¿s complaint description cannot be confirmed, and root cause remains inconclusive at this time.No correction is required at this time, and based on the low frequency, no recent trends, no issues noted in the dhr review, and adequate process controls in place, no corrective action is to be taken at this time.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 3ML L/L PC RED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915310
• Report Number: 1417592-2026-51991
• Device Sequence Number: 20169633
• Product Code: FMF
• UDI-Device Identifier: 40884389680576
• UDI-Public: 40884389680576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103736
• 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): 09/25/2026

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: DYNJSYRPC3R
• Device Lot Number: 23CBJ793
• Was Device Available for Evaluation?: Yes
• 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: 06/16/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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