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

Model Number	LCB048
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bi media is water-based and nontoxic.The reported event is attributed to improper handling or activation of the biological indicator by user facility personnel.The celerity steam biological indicator instructions for use include the process for proper activation of the bi, "to activate the bi, twist the cap clockwise while holding the vial to close the bi cap.(2) transfer the media from the cap to the vial by holding the bi firmly by its cap and flicking the wrist once.(3) the bi is properly activated when the cap is seated tightly on the vial and the media has come in contact with the spores on the bottom of the vial.(4) the media in the bottom of the vial will be purple." the investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that as an employee opened a celerity 20 steam bi the media splashed into their eye resulting in an injury.Medical treatment was sought and administered (eye flush).
Additional Manufacturer Narrative
A steris account manager provided in-service training on the proper handling and activation of the celerity 20 steam bi.No additional issues have been reported.

• 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: 14458873
• Report Number: 3004080920-2022-00003
• Device Sequence Number: 4597028
• Product Code: FRC
• UDI-Device Identifier: 10724995161542
• UDI-Public: 10724995161542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/19/2022

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
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 04/22/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/30/2022; 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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