MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; CHEMICAL INDICATOR

Model Number	STEAM INTEGRATING
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris made multiple attempts to obtain information regarding the reported event from the user facility however, the user facility has not responded.As the user facility has not responded and the subject device was not returned for evaluation, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch: mw5171758 that their verify steam integrating indicators are giving "inconsistent results." no report of injury.

• 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: 22669035
• Report Number: 3007412809-2025-00003
• Device Sequence Number: 3824809
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: (01)10724995002098(17)300301(10)325A
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STEAM INTEGRATING
• Device Catalogue Number: PCC064
• Device Lot Number: (10)325A
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/30/2025
• 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