MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 16FR10ML100%SIL UMS SNP

Catalog Number	URO175816S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "additionally, since we¿ve switched to these non-metal clip foleys, the securement device does not stop the foley access ports from laying the skin.They continue to push into the patient skin and are worrisome for pressure injuries and, again, getting skin flora into the catheter and on the access ports.".
Additional Manufacturer Narrative
Medline quality received a complaint regarding skin irritation due to the sample port; the facility reported sample port skin discomfort, pressure injury concerns, and that the securement device does not stop the foley access ports from laying the skin.Medline quality received 1 ea of the reported product in unpackaged, unused condition, and visual assessment revealed that the catheter was secured within a snapsecure securement device; examination of the catheter to urine meter assembly found that the sample port orientation was slightly imperfect, but did not exceed 90 degrees from the correct position, and the catheter was secured in the device with no issue.The reported issue of skin irritation could not be verified based on visual or functional inspection of the received sample; based on the description of the issue, some possible root causes could be, but are not limited to, securement device positioning, or patient positioning.A post-market retrospective review of the past 24 months preceding the reported issue revealed 0 additional complaints of sample port skin irritation, there are currently no known trends for this product, and 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: 1LYRTR 16FR10ML100%SIL UMS SNP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50757394
• Report Number: 1417592-2026-39700
• Device Sequence Number: 9550528
• Product Code: OHR
• UDI-Device Identifier: 40193489988308
• UDI-Public: 40193489988308
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: URO175816S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2024
• 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: 12/17/2024
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown