MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP

Catalog Number	DYNDTN1603
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "recently when they connect the syringe and to the extension and the extension to the primary set the syringe will not push the fluid through.The syringe will push when connected to either one independently just not as a set.".
Additional Manufacturer Narrative
The customer reported that the syringe will push when connected to either the extension set or the primary set independently, just not as a set.A sample was received for the investigation; due to the high volume of complaints regarding the same issue and item, medline did not test the samples and sent them to the vendor, amsino, for further evaluation, and notified the vendor and requested review of the production records.Based on the complaint details and investigation, medline confirmed the issue.Amsino's investigation determined that the defect originates during the assembly bonding process, where tubing was bonded such that it extended into the inner diameter of the male luer, resulting in interference between the tubing and the internal features of a needle-free site upon connection, which blocked or severely limited fluid flow through the connection; a corrective action request was issued to amsino and the supplier quality team will monitor this issue for trending purposes.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,60",2.0ML, M/F LUERLOCK,CLAMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898380
• Report Number: 1417592-2026-50985
• Device Sequence Number: 16142862
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: DYNDTN1603
• Device Lot Number: 03322409A208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/27/2025
• 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