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

Model Number LCB048

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/19/2022

Event Type  malfunction  

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 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
• 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: 13551693
• MDR Text Key: 296385212
• Report Number: 3004080920-2022-00001
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995161542
• UDI-Public: 10724995161542
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LCB048
• Device Catalogue Number: LCB048
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 06/29/2022
• 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