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

Catalog Number	BCLLAD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood "shot out of the needle" following the removal of the vial.
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving a medline bcllad that shot out blood when removed; there was no reported death or serious injury associated with this event.At this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and the vendor conducted additional testing on retained samples from the same lot, including appearance inspection, self sealing performance of rubber cap, and production records inspection.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.The root cause cannot be determined, and medline is 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: BLOOD CULTURE, LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793088
• Report Number: 1417592-2026-42737
• Device Sequence Number: 9607528
• Product Code: JKA
• UDI-Device Identifier: 10193489189650
• UDI-Public: 10193489189650
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/15/2026

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: BCLLAD
• Device Lot Number: 897241200
• Was Device Available for Evaluation?: No
• 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: 10/23/2025
• Initial Report FDA Received Date: 09/16/2026
• 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