MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 14FR10ML100%SIL UMS SNP

Catalog Number	URO175814S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when urine dumped from meter to bag leaking occurred and noticed crack along the back side of urine meter and around corner.".
Additional Manufacturer Narrative
According to the customer, on 8/5/2025, a catheter was placed and urine was noted leaking from a "crack along the back side of the urine meter and around corner"; the customer stated that due to a "difficult foley placement" only the collection bag was replaced and the catheter stayed in place.Medline quality received 1 ea of the reported product, and visual assessment of the provided product revealed that the back of the urine meter was cracked, creating an opening near the "racetrack" of the urine meter.The reported issue of a cracked/damaged urine meter was verified by visual assessment of the provided samples.The vendor completed their investigation, and a review of their records, manufacturing process, and retained samples found no additional abnormalities or defects in their production; although the issue was verified with the received sample, a definitive root cause could not be determined, and there are no observable trends for this product and product lot.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: 1LYRTR 14FR10ML100%SIL UMS SNP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50777432
• Report Number: 1417592-2026-41132
• Device Sequence Number: 18811388
• Product Code: OHR
• UDI-Device Identifier: 10193489988291
• UDI-Public: 10193489988291
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/10/2026

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: URO175814S
• Device Lot Number: 0332412A005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2025
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown