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

Model Number	LCB044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	07/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) was reviewed for lot subject of the event and no abnormalities were noted.Retain testing for the subject lot was conducted and no issues were noted.The instructions for use states, "per the product ifu, the "caution" statement between steps 7 & 8 state: "caution: challenge packs and test configurations processed through vaporized hydrogen peroxide sterilization may contain residual hydrogen peroxide.Always wear gloves when handling the bi." in addition, the instructions for use states, "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 (see sds for vaprox® hc sterilant).Place the entire test pouch and its contents into a steam compatible container and follow the instructions for disposal provided below." no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was in the process of activating the celerity 20 hp biological indicator and observed "white spots" on their fingers.The employee sought treatment and placed their fingers in water.The employee was also advised to apply ointment (vaseline).

• Brand Name: THE 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: 17631820
• Report Number: 3004080920-2023-00004
• Device Sequence Number: 15071302
• Product Code: FRC
• UDI-Device Identifier: 10724995154230
• UDI-Public: 10724995154230
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 08/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: LCB044
• Device Lot Number: 20240218
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/28/2023
• Date Device Manufactured: 05/08/2023
• 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