MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CYSTO URETEROSCOPY

Catalog Number	DYNJ57039B
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ky was all over inside of pack when opened.Unable to use drapes/gowns due to ky being all over everything in the pack.
Additional Manufacturer Narrative
The account reported finding lube leaked in pack, and the customer stated they were unable to use drapes/gowns due to ky being all over everything in the pack.The pack production record was reviewed and there were no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue; the finished good pack build, account complaint history, component complaint history, and vendor batch record/customer complaint log/retain samples were also reviewed, and no sample or photo was received for medline's investigation.Based on the complaint details, medline was not able to confirm the defect, and the vendor was unable to confirm the complaint.Without a sample it is difficult to determine a true root cause for the reported issue; the vendor stated no further action is required at this time and will continue to monitor and trend complaints.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: CYSTO URETEROSCOPY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853102
• Report Number: 1417592-2026-47301
• Device Sequence Number: 21209318
• Product Code: LRO
• UDI-Device Identifier: 40193489353434
• UDI-Public: 40193489353434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: DYNJ57039B
• Device Lot Number: 24EBC880
• 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: 07/09/2024
• Initial Report FDA Received Date: 09/22/2026
• 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