MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 2-LAYER TRAY,FOLEY,100% SIL,16FR 10ML,LF

Catalog Number	DYND11523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the customer has had multiple kits that are leaking in use".
Additional Manufacturer Narrative
The customer reported multiple kits were leaking in use, and according to the customer, after the foley was placed urine was noted on the floor and there appeared to be a slow leak from the drainage port area, although no active leak was observed.Medline quality received 3 ea of the reported product in packaged, unused condition; visual assessment revealed no defects nor abnormalities, and functional testing was conducted by filling each drain bag with 2000ml of water and observing for leaks.The drain bags did not display any signs of leakage for 10 minutes, and the reported issue of leakage could not be verified based on visual or functional inspection of the received sample.Based on the description of the issue, some possible root causes could be, but are not limited to, external damage, drainage valve engagement, or an unverified product issue; there are currently no known trends for this product lot, and medline quality will continue to monitor for the issue through bi-weekly 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: 2-LAYER TRAY,FOLEY,100% SIL,16FR 10ML,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50695730
• Report Number: 1417592-2026-35109
• Device Sequence Number: 12235052
• Product Code: OHR
• UDI-Device Identifier: 40884389497297
• UDI-Public: 40884389497297
• 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): 09/04/2026

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: DYND11523
• Device Lot Number: 24DBO314
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2024
• 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: 09/26/2024
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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