MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET,IRRIGATION,CYSTO/TUR,90,SINGLE SPIKE

Catalog Number	DYND19120H
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: SET,IRRIGATION,CYSTO/TUR,90,SINGLE SPIKE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50670182
• Report Number: 1417592-2026-33760
• Device Sequence Number: 15760162
• Product Code: LJH
• UDI-Device Identifier: 10080196993819
• UDI-Public: 10080196993819
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/03/2026

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: DYND19120H
• Device Lot Number: 0332403A003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2024
• 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: 07/17/2024
• Initial Report FDA Received Date: 09/08/2026
• 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