MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAINBAG,ANTI-REFLUX TOWER,L/F,2000ML

Catalog Number	DYND25205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "several patients are reporting leaking issues occurring after approximately 2-3 weeks of use and in some cases even sooner.".
Additional Manufacturer Narrative
The customer reported a concern related to the urinary bag, with leaking issues occurring after approximately 2-3 weeks of use and in some cases even sooner.Medline quality did not receive a sample nor photographs of the reported product; a review of the inspection records for the reported item found no similar issues reported, and a post-market retrospective review revealed additional complaints of leakage with no trend based on lot numbers or location of the leak.The vendor was notified, and a review of their records, manufacturing process, and testing of retained samples found no defects or nonconformances in their production.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.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: DRAINBAG,ANTI-REFLUX TOWER,L/F,2000ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50903642
• Report Number: 1417592-2026-51434
• Device Sequence Number: 20333800
• Product Code: KNX
• UDI-Device Identifier: 10884389121207
• UDI-Public: 10884389121207
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: DYND25205
• Device Lot Number: 0692505H011
• 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: 01/16/2026
• Initial Report FDA Received Date: 09/25/2026
• 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