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

Model Number	LCB053
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their celerity 20 steam process challenge device contained a dry biological indicator which was "affecting the caseloads and patient care" for the facility.
Additional Manufacturer Narrative
Retain testing was performed on the lot number subject of the reported event; no issues were noted.The dhr for the subject lot was reviewed and no abnormalities were found.The reported event may be attributed to inadvertent damage of the biological indicator prior to use by user facility personnel.The celerity 20 steam process challenge device bi instructions for use state "before use, examine the pcd to ensure that the foil and seal are intact.Examine the integrator through the plastic, to ensure the pcd has not been used previously.Do not use the celerity 20 steam pcd if the seal has been broken and the foil is not intact." a follow-up will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: CELERITY 20 STEAM PROCESS CHALLENGE DEVICE
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16645856
• Report Number: 3004080920-2023-00003
• Device Sequence Number: 17681562
• Product Code: FRC
• UDI-Device Identifier: 10724995161566
• UDI-Public: 10724995161566
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/30/2023

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: LCB053
• Device Catalogue Number: LCB053
• Device Lot Number: 20240514
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/30/2023
• Date Device Manufactured: 12/07/2022
• 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