MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR VENT 100%SIL UM 18FR COUDE

Catalog Number	URO180818C
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the "10ml syringe did not properly connect to the inflation port and sprayed saline all over caregiver." the customer reported that the foley was replaced.The customer also stated that there was "no indication of any additional follow-up needed with the patient".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 "10ml syringe did not properly connect to the inflation port and sprayed saline all over caregiver." the customer reported that the foley was replaced.

• Common Device Name: 1LYRTR VENT 100%SIL UM 18FR COUDE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes dr.; northfield, IL 60093
• MDR Report Key: 22396533
• Report Number: 1417592-2025-00327
• Device Sequence Number: 8574125
• Product Code: OHR
• UDI-Device Identifier: 10193489669749
• UDI-Public: 10193489669749
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: URO180818C
• Device Lot Number: 24KBL883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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