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

Catalog Number	DYND12574H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "he connects the bag, then when he gets up the urine drips out of the emptying valve without the valve being open.".
Additional Manufacturer Narrative
The patient reported to the nurse that he connects the bag, then when he gets up the urine drips out of the emptying valve without the valve being open.Medline quality received 3 ea of the reported product; the product was received in packaged, unused condition, visual assessment revealed no defects nor abnormalities, functional testing showed the valve functioned as normal with no signs of leakage, and a hang test revealed no defects nor abnormalities.The reported issue of twist-valve leakage could not be verified based on visual or functional inspection of the received sample, and the cause was not confirmed with the received sample.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: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898620
• Report Number: 1417592-2026-51022
• Device Sequence Number: 10761485
• Product Code: KNX
• UDI-Device Identifier: 10080196990337
• UDI-Public: 10080196990337
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/24/2026

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: DYND12574H
• Device Lot Number: 96924070001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2025
• 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: 01/31/2025
• Initial Report FDA Received Date: 09/25/2026
• 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