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	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "cust purchased one last year and leaked and he purchased one again last month and leaked all over his carpet.".
Additional Manufacturer Narrative
The customer reported drain bag leakage and stated that one purchased last year leaked and one purchased again last month leaked all over his carpet.Medline quality received photographs of the labeling and bag, but the defect was not captured clearly in the product photo; a post-market retrospective review of the past 24 months preceding the reported issue revealed 42 additional complaints of leakage with respect to this product, of which 3 are confirmed.It was later reported by the customer that they were able to recreate the issue when opening the drainage valve in the upright position in the drainage port housing, leakage occurred, and the customer noted that they may have forgotten to close the drain valve before bed.Based on this information, this complaint is determined to be not a product defect, and the cause was adjusted to misuse/mishandling.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: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896221
• Report Number: 1417592-2026-50707
• Device Sequence Number: 17642640
• Product Code: KNX
• UDI-Device Identifier: 10080196828685
• UDI-Public: 10080196828685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: DYND15205
• Device Lot Number: 0692402H011
• 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: 10/09/2025
• 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