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

Model Number LCB048

Device Problem Leak/Splash (1354)

Patient Problem Eye Pain (4467)

Event Date 04/21/2022

Event Type  malfunction  

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 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).

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
• Type of Device: 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
• MDR Text Key: 292211738
• Report Number: 3004080920-2022-00003
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995161542
• UDI-Public: 10724995161542
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LCB048
• Device Catalogue Number: LCB048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 04/22/2022
• Supplement Dates FDA Received: 06/30/2022; 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1