MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; CHEMICAL INDICATOR

Model Number	STEAM INTEGRATING
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that their verify steam integrating indicator leaked resulting in a procedure delay as the instruments had to be reprocessed prior to use.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, a cause of the reported event could not be determined.The dhr for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.A complaint review determined that this is an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: VERIFY
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer (Section G): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22186817
• Report Number: 3007412809-2025-00002
• Device Sequence Number: 18315568
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: (01)10724995002104(17)300101(10)125B
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: STEAM INTEGRATING
• Device Catalogue Number: PCC065
• Device Lot Number: (10)125B
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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