MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,1LYR 8FR5ML 100%SIL URN METER

Catalog Number	URO170808
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that staff had difficulty inflating and deflating the balloon during use.Multiple trays were attempted; two failed to inflate inside the patient, and a third inflated outside but did not fully deflate.Fourth attempt was successful.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
It was reported that staff had difficulty inflating and deflating the balloon during use.Multiple trays were attempted; two failed to inflate inside the patient, and a third inflated outside but did not fully deflate.Fourth attempt was successful.

• Common Device Name: TRAY,1LYR 8FR5ML 100%SIL URN METER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23511250
• Report Number: 1417592-2025-00617
• Device Sequence Number: 9613421
• Product Code: OHR
• UDI-Device Identifier: 10889942213467
• UDI-Public: 10889942213467
• 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): 11/10/2025

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: URO170808
• Device Lot Number: 25EBS674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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: Other
• Patient Age: 3 YR
• Patient Sex: Female