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

Model Number	STEAM INTEGRATING
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the verify steam integrating indicator had no paper in it after processing.User facility personnel were not able to use the instruments from the tray subsequently causing a procedure delay.No report of injury.
Additional Manufacturer Narrative
The steris sales representative stated that the verify steam integrating indicator subject of the reported event was discarded and was not available for evaluation.The sales representative stated that no additional verify steam integrating indicators from the subject lot were available for return/evaluation.Without the evaluation of the subject indicator, a root cause cannot be determined.The instructions for use states, "the integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other container to function as an independent monitor of critical parameters for the following sterilization cycles:" "the verify steam integrating indicator is part of a quality control system for sterility assurance.They cannot be used as a sole means for validating the sterilization process." the steris sales representative provided the user facility with replacement product.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only.Alignment with gudid.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: VERIFY
• Common Device Name: VERIFY STEAM INTEGRATING 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: 18188202
• Report Number: 3000251274-2023-00003
• Device Sequence Number: 15257741
• Product Code: JOJ
• UDI-Device Identifier: 10724995002098
• UDI-Public: (01)10724995002098(17)280301(10)323B
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 11/21/2023

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: STEAM INTEGRATING
• Device Catalogue Number: PCC064
• Device Lot Number: (10)323B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/22/2025; 01/22/2025; 01/22/2025
• 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