MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET,IRRIGATION,CYSTO,Y-TYPE,90

Catalog Number	DYND19122
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they leak at the connection.".
Additional Manufacturer Narrative
The customer reported the affected irrigation sets "leak at the connection." urology qa launched an investigation with product testing, placing the product on hold, testing at the dvv lab to confirm discrepancies between old and new lots, and validating a replacement vendor.After extensive testing, the dvv lab was able to confirm failures in the associated lots from customer complaints; the vendor confirmed that the tubing issue was the result of a compromised batch of raw material from their supplier.Urology qa opted to freeze all sales and move to the new vendor, and stated that the disconnections were determined to not pose immediate health hazards to the patient and that repeated regulatory investigations did not identify any direct patient harm nor medical intervention.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: SET,IRRIGATION,CYSTO,Y-TYPE,90
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856545
• Report Number: 1417592-2026-47915
• Device Sequence Number: 21206853
• Product Code: LJH
• UDI-Device Identifier: 40080196993827
• UDI-Public: 40080196993827
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K970946
• 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): 09/21/2026

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: DYND19122
• Device Lot Number: 18322060001
• 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: 04/03/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown