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

Catalog Number	LLAD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿lot# 89724040002 is leaking from the blue neck leading to the needle.¿.
Additional Manufacturer Narrative
According to the customer, there is ¿leaking from the blue neck leading to the needle¿ causing ¿blood to leak from the device¿; the customer reported there was no patient or user impact and no serious injury, medical intervention, or follow up care.Medline received 1cs, llad luer lock access device in new condition, randomly selected 20 samples for visual and functional testing, and used a 21g medline blood collection set with a venipucture blood board to simulate blood sample collection while observing for fluid leakage.A visual inspection revealed no manufacturing defects, functional testing showed no leaking, and the complaint was not confirmed.The samples worked as intended, and based on the review, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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 Indstries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946240
• Report Number: 1417592-2026-54204
• Device Sequence Number: 21445608
• Product Code: JKA
• UDI-Device Identifier: 20193489103219
• UDI-Public: 20193489103219
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/28/2026

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: LLAD
• Device Lot Number: 89724040002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2024
• 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: 07/22/2024
• 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