MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 6.5", 0.7ML, NONBOND NF

Catalog Number	DYNDTC5077
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "we have had intermittent issues with not being able to flush.Today, 6 of the sets in a row would not flush.We tried different ns flushes, and they would not flush.The clamp was not engaged, and the luer lock was secure.".
Additional Manufacturer Narrative
The account reported finding unable to flush extension set; the customer reported that 6 of the sets in a row would not flush, different ns flushes were tried, the clamp was not engaged, and the luer lock was secure.A sample was received for investigation; to evaluate the sample, medline connected a syringe to the device and pressed on the plunger, and at first the syringe plunger would not move and medline was unable to flush the device, however after playing around with the device for a bit, medline was able to flush the extension set.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed.Medline was unable to determine the exact root cause for why the device could not be flushed initially but later could be flushed, and the complaint was provided to the manufacturing facility for further evaluation while the division 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, 6.5", 0.7ML, NONBOND NF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856534
• Report Number: 1417592-2026-47909
• Device Sequence Number: 9498275
• Product Code: FPA
• UDI-Device Identifier: 10080196141883
• UDI-Public: 10080196141883
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/22/2026

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: DYNDTC5077
• Device Lot Number: 24125259
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2025
• 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: 11/17/2025
• Initial Report FDA Received Date: 09/22/2026
• 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