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

Catalog Number	DYNDST1545
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue is that when they try to adjust the flow to 50% by using the roller nothing happens¿the fluid still drains at 100%.When the roller is adjusted the fluid drain rate is either 100% or 0.There isn¿t anything in between when you adjust the roller.".
Additional Manufacturer Narrative
The account reported finding roller clamp doesn't work; when they try to adjust the flow to 50% by using the roller nothing happens, and the fluid drain rate is either 100% or 0.No sample or photo received for our investigation; finished good production records were reviewed, and the vendor returned their investigation and did not find any discrepancies in the production records nor evaluation of retained samples.Based on the complaint details, our investigation and the vendor's investigation, the complaint cannot be confirmed; sample required to determine cause.No patient effects/injury noted, and the division will monitor the issue through trending.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: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883325
• Report Number: 1417592-2026-49812
• Device Sequence Number: 21288686
• Product Code: FPA
• UDI-Device Identifier: 10884389975961
• UDI-Public: 10884389975961
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 0332410A193
• 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: 05/30/2025
• Initial Report FDA Received Date: 09/24/2026
• 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