MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 8", 0.3ML, NONBOND NF VA

Catalog Number	DYNDTC5081
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it doesn't work the blood/solution just pours through it onto the ground.".
Additional Manufacturer Narrative
It was repoted that the solution just pours through, and stated that the solution "comes out the end that is open" and that with other tubing they "never had to clamp it to keep it from coming out the end." no sample or photo was received for investigation; finished good production records were reviewed, the vendor was notified, and the manufacturer later provided their investigation of records and retained samples.Based on the complaint details, further information obtained by the customer and the investigation, the complaint is not confirmed.It was determined that the issue was more of a customer preference rather than a quality issue, and the manufacturer did not find any discrepancies within their records or retained samples that could have contributed to the reported issue.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, 8", 0.3ML, NONBOND NF VA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853336
• Report Number: 1417592-2026-47339
• Device Sequence Number: 9651482
• Product Code: FPA
• UDI-Device Identifier: 10080196141913
• UDI-Public: 10080196141913
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/21/2026

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: DYNDTC5081
• Device Lot Number: 24115122
• 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: 03/26/2025
• Initial Report FDA Received Date: 09/22/2026
• 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