MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IV ADMIN SET, 15DRP, 3 NF PORTS, 109

Catalog Number	DYNDTN1545
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our surgery dept said that this case of tubing leaks.".
Additional Manufacturer Narrative
The account reported finding leaking tubing, and the customer clarified that the reported leaking occurred during patient use when the device was connected to insyte catheters.A sample was received for investigation; the customer returned unopened devices for review, and 10 samples were randomly selected, primed, and connected to a representative intravascular catheter interface for connection testing.For all samples evaluated, no leakage was observed at the connection site between the iv administration set and catheter, and the complaint is not confirmed.A root cause was not identified; evaluation of the returned samples did not confirm the reported issue.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-IV ADMIN SET, 15DRP, 3 NF PORTS, 109
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871215
• Report Number: 1417592-2026-49163
• Device Sequence Number: 9223608
• Product Code: FPA
• UDI-Device Identifier: 10080196760022
• UDI-Public: 10080196760022
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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: DYNDTN1545
• Device Lot Number: 25025391
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2026
• 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: 02/10/2026
• 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