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

Catalog Number	DYND19122
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "disconnections - connection to foley catheter is too small.".
Additional Manufacturer Narrative
The customer reported that ¿the cystoscopy/tur irrigation set (aka cbi tubing), the connection to the foley end is too small,¿ and that ¿urine/blood and normal saline leaked all over the bed and patient¿; the customer also reported the patient¿s bed and body was wet and increased risk of catheter associated infection, skin infection, and skin breakdown.Medline quality received 1 ea of the reported product in unpackaged, unused condition; visual assessment revealed no defects nor abnormalities, measurements of the connector dimensions met the specified criteria in the product drawings, and functional testing with a medline silicone 3-way foley catheter found no abnormalities with the connection strength and no leakage at the connection point.The reported issue of leakage and connection issues could not be verified based on visual or functional inspection of the received sample, and the cause was not confirmed with the received sample.Based on assessment of the received sample, this complaint is unconfirmed, and there are no observable trends for this product at this time.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: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896770
• Report Number: 1417592-2026-50754
• Device Sequence Number: 17605545
• Product Code: LJH
• UDI-Device Identifier: 10080196993826
• UDI-Public: 10080196993826
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/24/2026

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: DYND19122
• Device Lot Number: 0332411A026
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2025
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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