MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; BIOLOGICAL INDICATOR

Model Number	S3061, S3069, S3065
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Steris was contacted on (b)(6) 2025 regarding an alleged infection following a patient procedure occurring on (b)(6) 2023.It was reported that the verify dual species self contained biological indicator and verify disposable biological steam test pack were used with the sterilizer at the user facility.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: VERIFY
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23425170
• Report Number: 3004080920-2025-00001
• Device Sequence Number: 9536462
• Product Code: FRC
• UDI-Device Identifier: 10724995023833
• UDI-Public: (01)10724995023833
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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 Model Number: S3061, S3069, S3065
• Device Catalogue Number: S3061, S3069, S3065
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown