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

Catalog Number	DYNDST1545
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "something is wrong with the clamp.The clamp doesn¿t work properly so it is giving the patient too many fluids.".
Additional Manufacturer Narrative
The customer reported that something is wrong with the clamp and that the clamp doesn¿t work properly so it is giving the patient too many fluids.Medline received 1 ea (b)(6) iv administration set; the device was observed for any manufacturing defects or cosmetic defects, and upon functional testing the roller clamp was slid closed to prevent any flow of fluid and observed for any leaks, then readjusted to allow free-flow of liquid.The device worked as intended and the complaint was not confirmed.No further action was taken because objectionable trends were not seen for this issue; division has been informed and will continue to monitor trends.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: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896244
• Report Number: 1417592-2026-50713
• Device Sequence Number: 5903534
• Product Code: FPA
• UDI-Device Identifier: 20884389975968
• UDI-Public: 20884389975968
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 0332303A171
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2023
• 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: 08/10/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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