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

Catalog Number	DYND12574
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "2 count twist valve won't stay tight, leasks, very loose".
Additional Manufacturer Narrative
A complaint was received regarding the valve leaking and not staying tight with respect to the urinary leg drain bags with elastic straps, twist valve, medium, 600 ml.Medline quality received 2 ea of the reported product in unpackaged, used condition; visual assessment revealed no defects nor abnormalities, no abnormalities or signs of damage were observed on the valve threading, and functional testing found the valve was able to open and close and stopped the flow of water without issue.The reported issue of the valve leaking and failing to stay tight could not be verified based on visual or functional inspection of the received sample, and the complaint is unconfirmed.The cause was not confirmed with the received sample, 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,MEDIUM,20OZ
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853871
• Report Number: 1417592-2026-47406
• Device Sequence Number: 15866063
• Product Code: KNX
• UDI-Device Identifier: 10080196990337
• UDI-Public: 10080196990337
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: DYND12574
• Device Lot Number: 96924090002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2025
• 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: 07/15/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown