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

Catalog Number	URO175816T
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the foley catheter was reading the patient's temperature at "84.5 deg fahrenheit", and upon further inspection it was discovered that the catheter was no longer inside the patient, and the catheter was noted to have a "deflated balloon".The customer reported that the foley was inserted on (b)(6) 2025 with "no issues".The customer reported due to the incident an additional foley was inserted.The customer did not report any serious injury, medical intervention, or follow up care related to the reported incident.No additional details are available related to the customer reported issue.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 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 customer, on (b)(6) 2025 the foley catheter was reading the patient's temperature at "84.5 deg fahrenheit", and upon further inspection it was discovered that the catheter was no longer inside the patient, and the catheter was noted to have a "deflated balloon".

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 16FR 10ML 100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24109296
• Report Number: 1417592-2026-00055
• Device Sequence Number: 17612199
• Product Code: OHR
• UDI-Device Identifier: 10193489988505
• UDI-Public: 10193489988505
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/19/2026

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: URO175816T
• Device Lot Number: 25HBE476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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