MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SOUTH BLOCK TRAY

Catalog Number	DYNJRA1625A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i have 3 samples from customer of leaking stopcocks from their south block tray dynjra1625a.".
Additional Manufacturer Narrative
The account reported three samples of leaking stopcocks from their south block tray.A sample was received for investigation, and the stopcocks were attached to a 20ml syringe filled with tap water to test the stopcocks for leaks.The reported issue was confirmed because the stopcocks failed their respective test due to a visible leak when the plunger was depressed on the syringe, and cracks in the white valve that directs the fluid path were found.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; the complaint has been provided to the component manufacturing facility for further evaluation, and the quality team will monitor this issue for trending purposes.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-SOUTH BLOCK TRAY
• 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: 50754199
• Report Number: 1417592-2026-39183
• Device Sequence Number: 18451828
• Product Code: OFT
• UDI-Device Identifier: 40195327219667
• UDI-Public: 40195327219667
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 09/09/2026

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: DYNJRA1625A
• Device Lot Number: 23BBN260
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2023
• 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: 06/02/2023
• Initial Report FDA Received Date: 09/14/2026
• 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