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	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported medwatch (b)(4) that the external indicator for the sterile tray changed color indicating sterilization, however the internal steam indicator color did not reach the end of the window.The blue color stopped in the middle of the window.No report of injury.
Additional Manufacturer Narrative
Steris requested the verify steam integrating indicator(s) back for evaluation.The verify steam integrating indicator subject of the reported event was not returned for evaluation.Without the return of the product, the root cause cannot be determined.The device review history (dhr) for the subject lot(s) were reviewed, and no abnormalities were found, and no other complaints associated with the subject lot.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.A follow-up report will be submitted should additional information become available.

• 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: 17611088
• Report Number: 3000251274-2023-00002
• Device Sequence Number: 12395734
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: 10724995002098
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/24/2023
• 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