MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LUER LOCK ACCESS DEVICE

Catalog Number	LLAD
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the plastic part covering the needle in the tube is sometimes leaking blood".
Additional Manufacturer Narrative
The customer reported that, on multiple occasions, "when we were using the transfer device the sheath that covered the needle did not auto retract and squirted blood out of the needle", and "we were not able to collect blood the first time and had to stick the patient again".Medline received 11ea llad luer lock access device in new condition, performed visual and functional testing on all 11ea samples, and used a 21g medline blood collection set and a venipucture blood board to simulate blood sample collection while observing for fluid leakage coming out from the needle rubber cover.The complaint was not confirmed; visual inspection revealed no manufacturing defects, functional testing showed no indications of leakage, and the samples worked as intended.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and there was no reported death or serious injury associated with this event.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: LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931838
• Report Number: 1417592-2026-52964
• Device Sequence Number: 13159043
• Product Code: JKA
• UDI-Device Identifier: 10193489103212
• UDI-Public: 10193489103212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200027
• 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): 09/17/2026

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: LLAD
• Device Lot Number: 89725030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2025
• 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: 11/10/2025
• Initial Report FDA Received Date: 09/29/2026
• 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