MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS VERIFY STEAM INTEGRATING INDICATOR; CHEMICAL INDICATOR

Model Number	PCC064
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the chemical within their verify steam integrating indicators did not completely enter the acceptance window following completed cycles resulting in procedure delays.The procedures were completed successfully.No report of injury.
Additional Manufacturer Narrative
A box of the indicators of the same lot number subject of the reported event were returned to steris for evaluation.A random sample of strips were tested, and the reported issue was duplicated in a small number of indicators; however, a specific root cause could not be determined.The verify steam integrating indicator is used to verify that sterilization conditions were met during a cycle.The operator removes the indicator and confirms that the chemical has traveled into the acceptance window which indicates a passing result.Steris will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: VERIFY STEAM INTEGRATING INDICATOR
• Common Device Name: CHEMICAL 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: 16845408
• Report Number: 3000251274-2023-00001
• Device Sequence Number: 7516060
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: 10724995002098
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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: PCC064
• Device Catalogue Number: PCC064
• Device Lot Number: 1022A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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