MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BAG,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ

Catalog Number	DYND12578H
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the twist valve won't stay closed.When wearing it, the valve starts to open due to friction.".
Additional Manufacturer Narrative
Customer states that the twist valve won't stay closed; when wearing it, the valve starts to open due to friction, and the bottom valve won't keep closed when full.Medline quality received returned product in unused condition; visual assessment revealed no defects nor abnormalities, and functional testing filled the leg bags with water and found the valve did not release a full stream of water until rotated greater than 90 degrees, meeting product specifications.Functional testing revealed no defects nor abnormalities, and based on the assessment of the returned samples and current product lot trends, this complaint is unconfirmed.There are currently no known trends for this product lot, and medline quality will continue to monitor for the issue through monthly complaint meetings and quarterly trending analysis.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: BAG,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50846192
• Report Number: 1417592-2026-46922
• Device Sequence Number: 10270353
• Product Code: KNX
• UDI-Device Identifier: 10080196990320
• UDI-Public: 10080196990320
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: DYND12578H
• Device Lot Number: 65625060001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2025
• 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: 12/04/2025
• Initial Report FDA Received Date: 09/21/2026
• 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