MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BAG,LEG,TWIST-VALVE,STRAPS,MEDIUM,20OZ

Catalog Number	DYND12574
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "so far two bags will not close tightly.".
Additional Manufacturer Narrative
The customer advised that she ordered 10 ea from betty mills and reported that two bags will not close tightly; the issue did not occur during use.Medline quality received 8 ea of the reported product in packaged, unused condition, conducted a visual assessment that revealed no defects nor abnormalities, and conducted functional testing by filling the leg bags with water and opening and closing the valve.The valve was able to start and stop the flow of water without issue, and the reported issue of valve closure could not be verified based on visual or functional inspection of the received sample.The cause was documented as not confirmed with received sample, and based on the investigation, this complaint is not confirmed; there are currently no known trends for this product lot.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,MEDIUM,20OZ
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858424
• Report Number: 1417592-2026-48102
• Device Sequence Number: 13268342
• Product Code: KNX
• UDI-Device Identifier: 10080196990337
• UDI-Public: 10080196990337
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/18/2026

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: DYND12574
• Device Lot Number: 65624110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2025
• 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: 07/14/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown