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

Catalog Number	DYNC1674H
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "per the nurse, the bag does not last a month and their patient is having to change the bags every week due to cracking/ripping in the bag.Nurse advised the bag tears specifically where the bag drains.".
Additional Manufacturer Narrative
The nurse called in to report a quality complaint for urinary drainage bags; the bag does not last a month and the patient is having to change the bags every week due to cracking/ripping in the bag, and the nurse advised the bag tears specifically where the bag drains.Medline quality did not receive a sample nor photographs of the reported product, and a post-market retrospective review of the past 24 months preceding the reported issue revealed (b)(4)additional complaints of leaking.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.If a product is received or more information is made available, the complaint will be reopened and an investigation will be performed; medline quality will continue to monitor for the issue through monthly complaint meetings and quarterly trending analysis.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,UROLOGY,2000ML,ANTI REFLUX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899115
• Report Number: 1417592-2026-51110
• Device Sequence Number: 18830957
• Product Code: KNX
• UDI-Device Identifier: 10080196840922
• UDI-Public: 10080196840922
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: DYNC1674H
• Was Device Available for Evaluation?: No
• 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: 02/23/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown