MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYR TRY 16FR 10ML 100% SILTMP SNP

Catalog Number	URO175814T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, nursing staff noted decreased urine output and performed a bladder scan that showed approximately 100 ml.The foley catheter was replaced with another medline temperature sensing foley, which subsequently also stopped draining.After removal of the second catheter, no further foley catheter was placed due to a change in the patient's code status, which the account stated was unrelated to the reported product issue.Nursing documentation also indicated intermittent episodes of larger urine outputs.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, on (b)(6) 2026, nursing staff noted decreased urine output and performed a bladder scan that showed approximately 100 ml.The foley catheter was replaced with another medline temperature sensing foley, which subsequently also stopped draining.After removal of the second catheter, no further foley catheter was placed due to a change in the patient's code status, which the account stated was unrelated to the reported product issue.Nursing documentation also indicated intermittent episodes of larger urine outputs.
Additional Manufacturer Narrative
Update to d4 and h6.After further investigation, it was determined that the correct catalog number of the device is uro175814t.The investigation included testing of the actual/suspected device and trend analysis.A blockage was identified, and the cause was traced to the user.If additional relevant information becomes available, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 16FR 10ML 100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24202867
• Report Number: 1417592-2026-00071
• Device Sequence Number: 9672160
• Product Code: OHR
• UDI-Device Identifier: 10193489988512
• UDI-Public: 10193489988512
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: URO175814T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown