MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET,IV,SMALLBORE EXT,7",REMOVABLE SL

Catalog Number	DYNDTN0001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was "having issues with the connecting threads leaking.Product unable to be used.".
Additional Manufacturer Narrative
The account reported finding connecting threads leaking, and the customer noted the product was unable to be used.A sample was received for investigation; 36 ea were received from the customer in their original packaging, and testing was performed on 15 ea chosen randomly by connecting an iv administration set to a saline bag, priming the setup, connecting a catheter to the device, and letting saline solution drip through for one minute while monitoring for leaking between the device and catheter.For each of the 15 received samples tested, there was no leaking and flow was consistent throughout the entire setup; based on the complaint details, sample evaluation, and investigation, the issue is not confirmed.No root cause was identified, 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.

• Brand Name: MEDLINE
• Common Device Name: SET,IV,SMALLBORE EXT,7",REMOVABLE SL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913867
• Report Number: 1417592-2026-51841
• Device Sequence Number: 12094815
• Product Code: FPA
• UDI-Device Identifier: 20888277403014
• UDI-Public: 20888277403014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: DYNDTN0001
• Device Lot Number: 0332310A198
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2024
• 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: 10/25/2024
• Initial Report FDA Received Date: 09/28/2026
• 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