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

Model Number	LCB048
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has made several attempts to obtain additional information regarding the reported event; however, to date the user facility has not responded.The bi media is water-based and not considered hazardous.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that an employee obtained a burn while handling a celerity 20 steam biological indicator (bi).The user facility did not disclose if medical treatment was sought or administered.

• Brand Name: CELERITY 20 STEAM 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: 13551693
• Report Number: 3004080920-2022-00001
• Device Sequence Number: 5236230
• Product Code: FRC
• UDI-Device Identifier: 10724995161542
• UDI-Public: 10724995161542
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/17/2022

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: LCB048
• Device Catalogue Number: LCB048
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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