MAUDE Adverse Event Report: STERIS CORPORATION CELERITY 20 HP BIOLOGICAL INDICATOR

Model Number	LCB044
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a "burn" while handling their biological indicator.The employee self-treated by rinsing the burn.It is unknown if additional medical treatment was sought or administered.
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.Investigation of the event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
During the steris sales representatives follow-up with user facility personnel, it is unable to be confirmed if the employee subject of the reported event was wearing proper ppe while handling the scbi.The instructions for use states, "caution: challenge packs and test configurations processed through vaporized hydrogen peroxide sterilization may contain residual hydrogen peroxide.Always wear gloves when handling the bi." "residual hydrogen peroxide may be trapped within the cap if the bi is damaged.Avoid direct contact with the bi and its contents, as it may result in a hydrogen peroxide chemical burn.Place the entire test pouch and its contents into a steam compatible container and follow the instructions for disposal provided below." steris offered in-service training on the proper use and operation of the scbi however, the user facility declined.

• Brand Name: CELERITY 20 HP BIOLOGICAL INDICATOR
• 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: 15328003
• Report Number: 3004080920-2022-00004
• Device Sequence Number: 17486476
• Product Code: FRC
• UDI-Device Identifier: 10724995154230
• UDI-Public: 10724995154230
• 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
• Report Date (Section B): 08/31/2022

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: LCB044
• Device Catalogue Number: LCB044
• Device Lot Number: 20230319
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 03/24/2023
• Date Device Manufactured: 06/01/2022
• 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