MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SET,IRRIGATION,CYSTO/TUR, SINGLE SPI

Catalog Number	DYND19140
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing is disconnecting from the stop cock very easily.
Additional Manufacturer Narrative
The complaint reported "tur tubing disconnecting"; the rn stated that it happened "multiple times during the case and to multiple patients throughout the day," and the complaint reported no patient or clinician harm and no medical intervention necessary.Medline quality did not receive a sample nor photographs of the reported product; a post-market retrospective review of the past 24 months preceding the reported issue revealed 1 additional complaints of loose tubing/disconnections with respect to the product.The vendor reviewed their batch records and retained samples and found no abnormalities or defects.This complaint is unconfirmed, as no samples nor photographs were made available to review; a root cause cannot be identified at this time, 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: DBD-SET,IRRIGATION,CYSTO/TUR, SINGLE SPI
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916831
• Report Number: 1417592-2026-52212
• Device Sequence Number: 12200712
• Product Code: LJH
• UDI-Device Identifier: 10884389942604
• UDI-Public: 10884389942604
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/25/2026

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: DYND19140
• Device Lot Number: 63724060002
• 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: 02/20/2025
• Initial Report FDA Received Date: 09/28/2026
• 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