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	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their verify steam integrating indicator leaked in the instrument set after processing.User facility personnel were not able to utilize the instrument set subsequently causing a procedure delay.No report of injury.
Additional Manufacturer Narrative
The user facility discarded the indicators subject of the reported event.Without product to evaluate, a root cause cannot be determined.The device history record for this lot was reviewed; no abnormalities were noted, the indicators were manufactured according to specifications.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 ; 4403927453
• MDR Report Key: 21076036
• Report Number: 3007412809-2025-00001
• Device Sequence Number: 6832146
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: (01)10724995002098(17)290801(10)824
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/05/2025

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: PCC064
• Device Lot Number: (10)824
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2025
• Supplement Report FDA Received Date: 03/25/2025
• 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