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

Model Number	PCC065B
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their verify steam integrating indicator leaked in the sterilized set resulting in a procedure delay.
Additional Manufacturer Narrative
Steris has contacted the customer for additional information regarding the reported event.To date, we have not received a response from the customer.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
The user facility discarded the indicators subject of the reported event.Without product to evaluate, a root cause cannot be determined.The lot history record for this lot was reviewed; no abnormalities were noted, the indicators were manufactured according to specifications.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: 18993843
• Report Number: 3000251274-2024-00002
• Device Sequence Number: 15354729
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: 10724995002104
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 03/28/2024

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: PCC065B
• Device Lot Number: 323D
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/13/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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