MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 30", 4.0ML, SLIDE CLAMP

Catalog Number	DYNDTA2006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "per staff they seem to be leaking at the hubs quite often.".
Additional Manufacturer Narrative
The customer reported that staff stated the devices seem to be leaking at the hubs quite often.No sample or photo was received for the investigation; finished good production records were reviewed, dhr cannot be reviewed since no lot number was provided, finished good pack build was not applicable, and component trending was reviewed with 0 additional reported complaints for this issue in the last 24 months.Based on the complaint details and investigation, the complaint is not confirmed, as no lot number, physical sample, or detailed photographic evidence was provided to support the investigation.Sample was required to determine cause, and 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, 30", 4.0ML, SLIDE CLAMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932352
• Report Number: 1417592-2026-53026
• Device Sequence Number: 18518858
• Product Code: FPA
• UDI-Device Identifier: 10888277655799
• UDI-Public: 10888277655799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/28/2026

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: DYNDTA2006
• 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: 08/25/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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