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	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿they are not letting propofol enter the tube and can¿t use them at all.¿.
Additional Manufacturer Narrative
According to the customer, the tubing ¿won¿t advance propofol¿; the customer reported no patient involvement or impact and did not report any serious injury, medical intervention, or follow up care related to the reported incident.A photo was received for the investigation, customer samples were provided, 15 samples were randomly selected for sample evaluation, and liquid was able to flush through the item when the female end of the sample was connected to the male end of an iv administration set.Based on the complaint details and investigation, the issue was confirmed.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; this interference blocked or severely limited fluid flow through the connection, and the complaint was provided to the vendor for further evaluation while supplier quality 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: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50839134
• Report Number: 1417592-2026-45949
• Device Sequence Number: 10301916
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/18/2026

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: 0332409A208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2025
• 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: 02/03/2025
• Initial Report FDA Received Date: 09/21/2026
• 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