MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 16FR 10ML 100% SILICONE FOLEY

Catalog Number	URO170716
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "it appears that the threads are stripped where the tubing attaches to the syringe.Today, the tubing actually snapped off, leaving the end attached to the syringe.".
Additional Manufacturer Narrative
Medline quality received a complaint regarding sample port difficulties; the customer reported that the "threads are stripped where the tubing attaches to the syringe" and that the "tubing snapped off, leaving the end attached to the syringe." based on the description, the reported issue is with the sample port component of the drain bag; medline quality did not receive a sample nor photographs, and a review of device history record for the reported item found no similar reported issues during inspection.The issue is unconfirmed, as no samples nor photographs were made available to review.A root cause cannot be identified at this time, and based on the findings of the quality investigation, no change has been made to the regulatory reportability decision for the complaint.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: 16FR 10ML 100% SILICONE FOLEY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793126
• Report Number: 1417592-2026-42745
• Device Sequence Number: 15813257
• Product Code: OHR
• UDI-Device Identifier: 40888277866912
• UDI-Public: 40888277866912
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/16/2026

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: URO170716
• Device Lot Number: 24DBP443
• Was Device Available for Evaluation?: No
• 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: 09/25/2024
• Initial Report FDA Received Date: 09/16/2026
• 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