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

Catalog Number	URO175816TS
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 after inserting the catheter it, "came out of the patient unintentionally and the balloon no longer had any liquid inside." the customer stated there were "leaks in the balloons." the customer stated, "the balloon leakage caused three foleys to dislodge and come out of the patient." the customer reported that after the final foley catheter insertion failed an external catheter was utilized.The customer reported the patient had been "on comfort care" and is now "deceased," but the patient death is "unrelated to the foley issue." no additional information is available at this time.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 after inserting the catheter it "came out of the patient unintentionally and the balloon no longer had any liquid inside." the customer stated there were "leaks in the balloons." the customer stated, "the balloon leakage caused three foleys to dislodge and come out of the patient.".

• Common Device Name: 1LYR TRY 16FR 10ML 100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23804786
• Report Number: 1417592-2025-00713
• Device Sequence Number: 7596335
• 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
• Report Date (Section B): 12/15/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: URO175816TS
• Device Lot Number: 25HBU775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 90 KG