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

Catalog Number	BCLLAD
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when removing the first bottle, the sheath over the needle did not retract back causing blood to leak out of the exposed needle.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood culture luer lock access device that was leaking during use; the customer also reported there was no impact to the patient or user and no serious injury, medical intervention, or follow up care related to the reported incident.Medline received 1ea bcllad blood culture luer lock access device in used condition; visual inspection noted that the sheath was fully retracted, covering the needle, but the sample had been used and was covered in blood, so no functional test could be performed, and reserve stock was ordered instead.When reserve stock was received, 29 samples were visually and functionally inspected, with no indications of manufacturing defects and no indications of leakage during or after testing.The complaint was not confirmed, no root cause was identified, and the samples worked as intended.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: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819098
• Report Number: 1417592-2026-44715
• Device Sequence Number: 15991924
• Product Code: JKA
• UDI-Device Identifier: 10193489189650
• UDI-Public: 10193489189650
• 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: BCLLAD
• Device Lot Number: 89724070001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2025
• 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: 04/07/2025
• Initial Report FDA Received Date: 09/18/2026
• 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