MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 15DRP, 2 NF PORTS, 108"

Catalog Number	DYNDST1512
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tubing attached primary line to catheter and not separate and luer lock was damaged.
Additional Manufacturer Narrative
Medline quality received a complaint that tubing attached primary line to catheter and not separate and luer lock was damaged.The complaint was re-opened due to receiving the sample; medline evaluated the tubing that was returned and did not observe any physical deformities or any damage.The reported concern was not confirmed with the received sample, and no root cause was identified.A retrospective review of the past year indicated that there have been no prior complaints in regard to this issue, and the division will continue to monitor this issue for 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, 2 NF PORTS, 108"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854988
• Report Number: 1417592-2026-47621
• Device Sequence Number: 18516064
• Product Code: FPA
• UDI-Device Identifier: 20884389975951
• UDI-Public: 20884389975951
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/21/2026

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: DYNDST1512
• Device Lot Number: 033230A168
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• 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: 12/27/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown