MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYR TRY 16FR 10ML 100% SIL UM SNAP

Catalog Number	URO175816S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Tract Infection (2120)
Date of Event	05/15/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that a patient with an existing cauti with foley catheter had "stool intrusion" in the catheter.The patient reportedly had "sudden decline in patient status and severe sepsis, required pressors and ultimately passed away".It was reported that the patient "had multiple medical issues, and she can't say for sure that the patient's death was due to cauti".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
Stool intrusion under seal of catheter to drainage bag connection.

• Common Device Name: 1LYR TRY 16FR 10ML 100% SIL UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22167580
• Report Number: 1417592-2025-00281
• Device Sequence Number: 15443187
• Product Code: OHR
• UDI-Device Identifier: 10193489988307
• UDI-Public: 10193489988307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/09/2025

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
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: URO175816S
• Device Lot Number: 25ABT195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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: Death
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 71 KG