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

Catalog Number	DYND15205
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drain bag was "torn on side.".
Additional Manufacturer Narrative
The reported failure was described as a drain bag torn on side and an "amazon customer w torn drainage connection right out of bag." medline quality received a photograph of the reported product and did not receive a sample; visual assessment of the provided photograph revealed a tear by the connection port of the drain bag.The reported issue was verified by visual assessment of the provided photograph, thus confirming the complaint.Based on the provided image and description of the issue, the likely root cause is external damage to product during production, storage or transport; medline urology qa has logged and trended this issue and will continue to monitor going forward.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: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915126
• Report Number: 1417592-2026-51960
• Device Sequence Number: 14800930
• Product Code: KNX
• UDI-Device Identifier: 40080196828686
• UDI-Public: 40080196828686
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/26/2026

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: 06/29/2023
• Initial Report FDA Received Date: 09/28/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown