MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 15DRP, 3 NF PORTS, 112"

Catalog Number	DYNDST1545
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they had the valves fail causing leak.".
Additional Manufacturer Narrative
According to the customer, the iv set "failed" due to "valves leaking" requiring the set to be replaced; the customer did not report any occurrence of adverse event related to the administration of medications, serious injury, medical intervention, or follow up care related to the reported incident.Functional inspection was conducted with the provided sample; medline tested the sample and hooked the tubing up to an iv bag, and the tubing was not leaking and functioned normally.The reported concern could not be confirmed, as no issues have been found, and the cause code description was not confirmed with received sample.The division will continue to monitor this issue for trending, and there has been no change to the reportability decision associated with this complaint.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: IV ADMIN SET, 15DRP, 3 NF PORTS, 112"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898269
• Report Number: 1417592-2026-50973
• Device Sequence Number: 14928430
• Product Code: FPA
• UDI-Device Identifier: 20884389975968
• UDI-Public: 20884389975968
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093773
• 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: DYNDST1545
• Device Lot Number: 0332311A090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2024
• 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: 02/27/2024
• Initial Report FDA Received Date: 09/25/2026
• 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