MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LUER LOCK ACCESS DEVICE

Catalog Number	ACSD
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they aren¿t pulling blood like they should." the customer also reported, "they also tried using a syringe to aspirate the needle and that failed as well.".
Additional Manufacturer Narrative
The reported issue was acsd luer lock access device not working properly; they aren¿t pulling blood like they should, and using a syringe to aspirate the needle failed as well.Medline received 1cs, acsd luer lock access device in new condition, randomly selected 20ea sample for testing, and performed functional testing utilizing a venipucture blood board to simulate blood sample collection.Medline was able to draw the "blood" with no issues, saw no indications of leakage coming from the needle rubber cover or the rubber cover not coming back to the initial position exposing the needle, and the complaint was not confirmed.The cause was not confirmed with received sample under unconfirmed defect; the samples worked as intended, and medline will continue to monitor this issue for trends.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: DBD-LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691813
• Report Number: 1417592-2026-34752
• Device Sequence Number: 18540647
• Product Code: FMI
• UDI-Device Identifier: 20193489006077
• UDI-Public: 20193489006077
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172763
• 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): 09/04/2026

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: ACSD
• Device Lot Number: 220630
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2023
• 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: 05/02/2023
• Initial Report FDA Received Date: 09/09/2026
• 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