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	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two of the four indicators subject of the reported event were returned to steris for evaluation.The additional two indicators were scrapped by the customer and not returned.The verify steam integrating indicator is used to verify that sterilization conditions were met during a cycle.For the two indicators that were tested, the reported issue was confirmed.It was determined that the indicators did not contain the minimum amount of chemical material to allow the ink pellet to reach the acceptance window.The dhrs for the lot numbers subject of the reported event were reviewed and no abnormalities were noted.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.No additional issues reported.
Event or Problem Description
The user facility reported that four of their verify steam integrating indicators did not completely enter the acceptance window following completed cycles resulting in the instruments having to be reprocessed.The facility reported procedure delays occurred as a result.The procedures were completed successfully.No report of injury.

• 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: 19184733
• Report Number: 3000251274-2024-00003
• Device Sequence Number: 6989333
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: 10724995002098
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/25/2024

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: PCC064
• Device Lot Number: 723A, 923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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