MAUDE Adverse Event Report: STERIS CORPORATION CELERITY; CELERITY 20 STEAM PROCESS CHALLENGE DEVICE

Model Number	LCB049
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported a positive biological indicator.The instruments had to be reprocessed resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
The lot history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.Additionally, during production and packaging, each individual fluorescent self-contained biological indicator (scbi) is visually inspected to ensure proper assembly.A positive scbi can be attributed to multiple causes.Since the scbi subject of the reported event was not available for evaluation, the exact cause for this event cannot be determined.There have been no other similar complaints for this lot.Steris will continue to monitor post-market data to ensure the product continues to perform as intended.No additional issues have been reported.

• Brand Name: CELERITY
• Common Device Name: CELERITY 20 STEAM PROCESS CHALLENGE DEVICE
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20737852
• Report Number: 3004080920-2024-00001
• Device Sequence Number: 8377150
• Product Code: FRC
• UDI-Device Identifier: 10724995161559
• UDI-Public: (01)10724995161559(17)260102(10)20260102
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 11/20/2024

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 Expiration Date: 01/02/2026
• Device Model Number: LCB049
• Device Catalogue Number: LCB049
• Device Lot Number: (10)20260102
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided; 11/18/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/25/2025; 02/26/2025
• 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