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

Model Number	PCC065
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The verify steam integrating indicator subject of the reported event has been returned to steris for evaluation.The instructions for use states, "the integrator demonstrates passing results when the bar has completely travelled through the "reject" area or window and has entered the "accept" area or window.Variability in the color of the bar is normal and acceptable as long as the bar is visible in the "accept" area or window." investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their verify steam integrating indicator did not "change in color" subsequently resulting in a procedure delay to occur.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 was not present.A complaint review confirms this to be an isolated event.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: 18505597
• Report Number: 3000251274-2024-00001
• Device Sequence Number: 20854961
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: 10724995002104
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 01/12/2024

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
• Device Model Number: PCC065
• Device Lot Number: 823
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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