MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET,IRRIGATION,4-LEAD,90

Catalog Number	DYND19124
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tubing keeps slipping off the stop cock and water is spraying out while the surgeon is using it.".
Additional Manufacturer Narrative
The customer reported issues with the cysto tubing (4 lead) that comes in custom packs from cardinal; the tubing keeps slipping off the stop cock and water is spraying out while the surgeon is using it, and the 4 lead rubber is really soft.Urology qa launched testing at the dvv lab, confirmed failures in the associated lots from customer complaints, and included the 4-lead version of the product in testing.As this is a known defect, documented by both the vendor and urology qa, this complaint and any others describing this issue will be confirmed; the tubing issue was the result of a compromised batch of raw material from the vendor's supplier.The customer reported no patient was involved, the surgery was able to be completed, and no serious injury or medical intervention/attention was required.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,4-LEAD,90
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50752559
• Report Number: 1417592-2026-38967
• Device Sequence Number: 9203171
• Product Code: LJH
• UDI-Device Identifier: 40080196993834
• UDI-Public: 40080196993834
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/09/2026

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: DYND19124
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2023
• 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: 02/15/2023
• Initial Report FDA Received Date: 09/14/2026
• 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