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

Catalog Number	DYND15207
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿qty 1 ea 6015207 dynd15207 leaked at side seam.¿.
Additional Manufacturer Narrative
The customer reported that one drainage bag ¿leaked at side seam,¿ and the customer discarded the item.Medline¿s investigation noted ¿sample/photo provided: none¿ and that ¿there were no samples or pictures received.¿ investigation results were ¿not confirmed,¿ and the ¿root cause¿ was ¿not confirmed/no sample received.¿ without a sample received, it is difficult to determine a true root cause for the reported issue; the division performs quarterly trending on all complaints received and will reopen the complaint if a sample, photo, and/or additional information becomes available.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 DEVICE,2000ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50694033
• Report Number: 1417592-2026-34977
• Device Sequence Number: 21253987
• Product Code: KNX
• UDI-Device Identifier: 40080196446019
• UDI-Public: 40080196446019
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/09/2026

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: DYND15207
• 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: 02/28/2024
• Initial Report FDA Received Date: 09/09/2026
• 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