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

Model Number LCB044

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

The user facility reported that an employee obtained a "burn" after handling their celerity 20 hp biological indicator.The employee washed their hands and went to the er.

Manufacturer Narrative

The celerity 20 hp biological indicator had been processed in a v-pro sterilizer.Following a completed cycle, the employee proceeded to pick up the indicator and felt a burning sensation on their hands.The employee subject of the reported event was not wearing proper ppe, specifically gloves while handling the biological indicator.The instructions for use states, "caution: challenge packs and test configurations processed through vaporized hydrogen peroxide sterilization may contain residual hydrogen peroxide.Always wear gloves when handling the bi." "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.Place the entire test pouch and its contents into a steam compatible container and follow the instructions for disposal provided below." a steris sales representative provided in-service training materials to the user facility on the proper use and handling of the celerity 20 hp biological indicator.As the lot number was not provided by the user facility, steris is unable to conduct a dhr review and retain testing.No additional issues have been reported.

• Brand Name: CELERITY 20 HP 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: 15693195
• MDR Text Key: 307167590
• Report Number: 3004080920-2022-00006
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995154230
• UDI-Public: 10724995154230
• 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
• Report Date: 10/28/2022

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: LCB044
• Device Catalogue Number: LCB044
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/28/2022
• 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