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	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer.Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).
Additional Manufacturer Narrative
According to the facility, the temp foley kit was inserted in patient on (b)(6) am.The patient went to the or for "egd and colonoscopy" and upon arrival back to the icu, the urine was leaking around the catheter and removed and "it easily slid out of the urethra.Balloon noted to be deflated." the rn attempted to fill the balloon to test and "found a hole" in the balloon.New temp foley kit was inserted with "no issues." no additional information at this time.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, the temp foley kit was inserted in patient on (b)(6) am.The patient went to the or for "egd and colonoscopy" and upon arrival back to the icu, the urine was leaking around the catheter and removed and "it easily slid out of the urethra.Balloon noted to be deflated.".

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 16FR 10ML 100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 24111495
• Report Number: 1417592-2026-00056
• Device Sequence Number: 13358971
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/04/2026
• 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
• Patient Sex: Unknown