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

Model Number LCB044

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Discoloration (2074)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) was reviewed for lot subject of the event and no abnormalities were noted.Retain testing for the subject lot was conducted and no issues were noted.The instructions for use states, "per the product ifu, the "caution" statement between steps 7 & 8 state: "caution: challenge packs and test configurations processed through vaporized hydrogen peroxide sterilization may contain residual hydrogen peroxide.Always wear gloves when handling the bi." in addition, the instructions for use states, "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 (see sds for vaprox® hc sterilant).Place the entire test pouch and its contents into a steam compatible container and follow the instructions for disposal provided below." no additional issues have been reported.

Event Description

The user facility reported that an employee was in the process of activating the celerity 20 hp biological indicator and observed "white spots" on their fingers.The employee sought treatment and placed their fingers in water.The employee was also advised to apply ointment (vaseline).

• Brand Name: THE 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: 17631820
• MDR Text Key: 322059754
• Report Number: 3004080920-2023-00004
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995154230
• UDI-Public: 10724995154230
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 08/28/2023

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 Lot Number: 20240218
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/28/2023
• Date Device Manufactured: 05/08/2023
• 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