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

Catalog Number	BCLLAD
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the new blood culture cavutainers are very flimsy and the needles are bending and breaking frequently.A nurse said the needle continued to drip a large amount of blood after he deisengaged a blood culture bottle yesterday.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood culture luer lock access device that has a flimsy/bending blood culture, and reported ¿blood culture flimsy bending and break.¿ medline attempted to get more information; no additional information was provided by the customer, and testing was conducted using bcllad alongside bd vacutainer tubes, with 3 vacutainer tubes for each bcllad to simulate a multiple blood draw using a phlebotomy training device with simulated skin and veins.All bcllads functioned as intended, no vacutainer tubes were loose, stuck, or any other defect, and all bcllad, vacutainer tubes, and needles were free from damage or defect; the investigation results were not confirmed.No root cause was identified, no trends were identified for the specified material number and corresponding defect type, and there was 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: BLOOD CULTURE, LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866932
• Report Number: 1417592-2026-48505
• Device Sequence Number: 18486778
• Product Code: JKA
• UDI-Device Identifier: 10193489189650
• UDI-Public: 10193489189650
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/22/2026

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: (10)89724120001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2026
• 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: 01/20/2026
• Initial Report FDA Received Date: 09/23/2026
• 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