MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; CHEMICAL INDICATOR

Model Number	STEAM INTEGRATING
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The verify steam integrating indicator of the reported event is unavailable for evaluation; the user facility has not responded to multiple requests for additional information.Without the return or inspection of the subject device, a root cause cannot be determined.The device history record for the subject lot was reviewed and confirmed the devices was manufactured to specifications; no abnormalities were noted.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.
Event or Problem Description
The user facility reported via user facility medwatch report (mw5159615) that there was no dye in the indicator to detect if it passed or failed.No report of injury.

• Brand Name: VERIFY
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer (Section G): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20686151
• Report Number: 3007412809-2024-00001
• Device Sequence Number: 8700625
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: (01)10724995002098(17)290501(10)524
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/14/2024

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: STEAM INTEGRATING
• Device Catalogue Number: PCC064
• Device Lot Number: (10)524
• 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: 10/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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