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

Catalog Number	ACSD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tip continues to break crack with no pressure.".
Additional Manufacturer Narrative
The customer reported tip breaking and stated that the tip continues to break crack with no pressure.A sample was not received for investigation; however, reserve stock from the warehouses with the same reported lot was ordered to test, and 30 samples were randomly selected for visual and functional testing using a medline 60" iv extension set.The complaint was not confirmed: visual inspection revealed no manufacturing defects, no issues were experienced during functional testing, the blue luer connector safely secured, and no breaking/cracking occurred.A root cause was not identified because a sample was required to determine cause; the samples worked as intended, and the division was informed and will continue to monitor 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: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50841445
• Report Number: 1417592-2026-46334
• Device Sequence Number: 21398348
• Product Code: FMI
• UDI-Device Identifier: 20193489006077
• UDI-Public: 20193489006077
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/18/2026

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: 220520
• Was Device Available for Evaluation?: Yes
• 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: 01/11/2023
• Initial Report FDA Received Date: 09/21/2026
• 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