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

Model Number	PCC065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The verify steam integrating indicators subject of the reported event were scrapped by the customer and 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 was reviewed, and no abnormalities were noted.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 to ensure the product continues to perform as expected.No additional issues have been reported.
Event or Problem Description
The user facility reported that their verify steam integrating indicators had leaked inside two instrument containers after processing.The leak was identified when the containers were opened in the or and the containers were sent for reprocessing resulting in a procedure delay.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: 19669167
• Report Number: 3000251274-2024-00004
• Device Sequence Number: 6836292
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: 10724995002104
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 07/03/2024

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: PCC065
• Device Lot Number: 1223
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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