MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-CEDIV ADMIN SET, 15DRP, SECOND, 40

Catalog Number	DYNDTB1540
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one was spiked into an acetaminophen bottle and when the tab was opened to allow in air in, it started leaking ¿ a lot.It was connected to the primary tubing that was hooked up to an iv pump.".
Additional Manufacturer Narrative
The account reported finding leaking; the customer reported the secondary tubing was spiked into an acetaminophen bottle and when the tab was opened to allow in air in, it started leaking, and it was connected to the primary tubing that was hooked up to an iv pump.No sample or photo received for our investigation; finished good production records were reviewed, the manufacturer was notified of this incident and requested a completed review of the production records, no investigation was received from the manufacturer after two follow ups, and component trending was reviewed with 0 additional reported complaints for this issue for component dyndtb1540 in the last 24 months.Based on the complaint details and our investigation, the complaint is not confirmed; at this time, we are unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation.Sample required to determine cause; this complaint has been provided to the vendor 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 ADMIN SET, 15DRP, SECOND, 40
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915974
• Report Number: 1417592-2026-52071
• Device Sequence Number: 5330484
• Product Code: FPA
• UDI-Device Identifier: 10197344098637
• UDI-Public: 10197344098637
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210381
• 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): 09/25/2026

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: DYNDTB1540
• Device Lot Number: BQ241052101
• 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: 07/21/2025
• Initial Report FDA Received Date: 09/28/2026
• 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