MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BAG,DRAINAGE,ANTI-REFLUX TOWER,2000ML

Catalog Number	DYND15205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "his urinary drain bag was leaking" and "its leaking all over his bed and home.".
Additional Manufacturer Narrative
The customer called in because his urinary drain bag was leaking and stated that it was leaking all over his bed and home.A sample and/or photo was requested, as well as the lot number; however, the customer was unable to provide a sample, photo, and lot information, and the customer was contacted and requested to provide additional information.Based on the results of the investigation and the lack of lot number information, medline was unable to confirm the complaint issue or that the product failed to meet specifications; the cause code text was "sample required to determine cause" and the cause was an unconfirmed defect.A review of the complaint information as well as the results of the investigation indicated no need for further action, and complaints are monitored via the (b)(4) trend analysis procedure.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,DRAINAGE,ANTI-REFLUX TOWER,2000ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50789784
• Report Number: 1417592-2026-42282
• Device Sequence Number: 9525297
• Product Code: KNX
• UDI-Device Identifier: 10080196828685
• UDI-Public: 10080196828685
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/15/2026

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: DYND15205
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/16/2026
• 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