MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 8", 0.3ML, NONBOND NF VA

Catalog Number	DYNDTC5081
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "for about the last 2 weeks we have been having an increasing number of extension sets difficult to flush or not working at all.Currently about ever other set if not every set has to be disassembled to get the needle free valve to work.".
Additional Manufacturer Narrative
The facility reported that "when prepping extension tubing for patients and priming the tubing the extension tubing in question could not push fluid through the valve" and "if the set was disassembled and the flush screwed onto the buff cap as tight as possible the set will finally pass fluids"; no medical intervention, serious injury, or follow-up care has been reported.The customer did not provide the sample for evaluation, and the pictures provided were only the pictures on the item not the issue; a retain sample was ordered for testing.At this time, the reported concern could not be confirmed, as medline was not able to investigate the issue.No root cause was identified, 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 EXT SET, 8", 0.3ML, NONBOND NF VA
• 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: 50898700
• Report Number: 1417592-2026-51024
• Device Sequence Number: 20290852
• Product Code: FPA
• UDI-Device Identifier: 40080196141914
• UDI-Public: 40080196141914
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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: DYNDTC5081
• Device Lot Number: 22125537
• 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: 07/01/2024
• Initial Report FDA Received Date: 09/25/2026
• 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