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	Exposure to Body Fluids (1745)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the grey rubber needle cover is not moving back over the needle once they draw blood and this causes blood to free flow.".
Additional Manufacturer Narrative
The customer reported there have been "several" incidents where the "rubber does not retract back over the needle and blood goes everywhere"; the customer reported the patients are doing "fine" and no serious injury, medical intervention, or follow up care.Samples received are used, and an unused sample was requested from the customer for testing.The reported problem could not be evaluated from the used samples received.No root cause was identified in the provided investigation record, and there has been no change to the reportability decision associated with this complaint.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: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915040
• Report Number: 1417592-2026-51953
• Device Sequence Number: 14801191
• Product Code: JKA
• UDI-Device Identifier: 20193489103219
• UDI-Public: 20193489103219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 89724040001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/28/2024
• 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: 06/25/2024
• Initial Report FDA Received Date: 09/28/2026
• 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