MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; IV EXT SET, 8", 1.6ML, NONBOND NF VALV

Catalog Number	DYNDTN2001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The the female luer lock disconnects very easily from the part that connects to the syringe/tubing.More concerning, however, is that while a patient was receiving iv fluids, the plastic tubing that connects to the luer lock seemingly broke off.There should be no loose attachment at this spot.
Additional Manufacturer Narrative
It was reported that the the female luer lock disconnects very easily from the part that connects to the syringe/tubing.More concerning, however, is that while a patient was receiving iv fluids, the plastic tubing that connects to the luer lock seemingly broke off.There should be no loose attachment at this spot.This is difficult to describe without a demonstration, and we based this finding on testing the product ourselves.We found that typically, twisting the luer lock end off requires purposeful effort because it is not designed to detach under normal circumstances.However, with this particular lot number, even a slight tug caused it to disconnect very easily.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.

• Brand Name: MEDLINE
• Common Device Name: IV EXT SET, 8", 1.6ML, NONBOND NF VALV
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25417273
• Report Number: 1417592-2026-02156
• Device Sequence Number: 10136818
• Product Code: FPA
• UDI-Device Identifier: 10193489004892
• UDI-Public: 10193489004892
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K093773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDTN2001
• Device Lot Number: 0332511A262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown