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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that on the syringe pump the tubing "would not deliver the medication," and when it was removed from the pump and delivery was attempted manually, "the solution would not advance"; it delayed care, causing increased anxiety in the patients, and no medical intervention, serious injury, or follow-up care was required.Medline documented that no sample or photo was received for this investigation, notified the vendor of this incident, requested a completed review of the production records, and provided customer samples from other complaints regarding the same issue and item to amsino for further evaluation.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 extended into the inner diameter of the male luer and interfered with the internal features of a needle-free site upon connection, blocking or severely limiting fluid flow; the complaint was provided to the vendor for further evaluation and 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.
Event or Problem Description
It was reported that "saline is not flowing through the tubing.".

• 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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931153
• Report Number: 1417592-2026-52859
• Device Sequence Number: 21522457
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/25/2026

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: 0332410A048
• 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: 02/24/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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