MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-CEDIV EXT SET,6.5,1.1ML, M LUERLOCK,

Catalog Number	DYNDTB5077
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood is suctioning back into the line and past the first port, it¿s leaking where she has marked the arrow on the photo attached.
Additional Manufacturer Narrative
The account reported finding leaking, and the customer also reported backflow with this product.A sample was received for investigation; the device was attached to the port of a primary set with a saline filled syringe, and it was also evaluated by connecting a catheter to the male luer and the saline syringe to the female luer.No leakage was observed at either end of the device, the complaint is not confirmed, and the reported issue could not be confirmed since no leakage was observed.(b)(6)does not have a check valve that would prevent the reported backflow issue; the complaint has been provided to the finished good manufacturing facility for further evaluation and the division 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: DBQ-CEDIV EXT SET,6.5,1.1ML, M LUERLOCK,
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884621
• Report Number: 1417592-2026-50045
• Device Sequence Number: 13218162
• Product Code: FPA
• UDI-Device Identifier: 10197344098651
• UDI-Public: 10197344098651
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242126
• 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): 09/24/2026

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: DYNDTB5077
• Device Lot Number: BQ250456601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2025
• 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: 10/27/2025
• Initial Report FDA Received Date: 09/24/2026
• 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