MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS VERIFY; VERIFY STEAM INTEGRATING 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	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The verify steam integrating indicator subject of the reported event is being sent back for evaluation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the indicator leaked blue ink into their instrument tray during a sterilization cycle.A procedure delay was reported as the instruments were reprocessed.No report of injury.
Additional Manufacturer Narrative
The verify steam integrating indicator subject of the reported event was sent back for evaluation.Evaluation results confirmed that the wicking strip within the verify steam integrating indicator had leaked out of the side of the indicator causing user facility personnel to observe the blue ink on their instrument tray.Steris will continue to monitor for similar events.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: VERIFY
• Common Device Name: VERIFY STEAM INTEGRATING INDICATOR
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18332609
• Report Number: 3000251274-2023-00004
• Device Sequence Number: 15555326
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: (01)10724995002098(17)280701(10)723A
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2023

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
• Device Model Number: STEAM INTEGRATING
• Device Catalogue Number: PCC064
• Device Lot Number: (10)723A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023; Not provided; Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/11/2024; 01/22/2025; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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