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

Catalog Number	URO175816TS
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Temperature sensing foley catheter was placed in the patient.During routine rounding, the rn noted that the foley was not draining appropriately.Upon inspection, the foley was found to have come out, and the balloon appeared to have deflated.A new temperature sensing foley catheter was obtained for replacement.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
Temperature sensing foley catheter was placed in the patient.During routine rounding, the rn noted that the foley was not draining appropriately.Upon inspection, the foley was found to have come out, and the balloon appeared to have deflated.A new temperature sensing foley catheter was obtained for replacement.

• 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: 23906235
• Report Number: 1417592-2025-00744
• Device Sequence Number: 9194336
• Product Code: OHR
• UDI-Device Identifier: 10193489988512
• UDI-Public: 10193489988512
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO175816TS
• Device Lot Number: 25HBU775
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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