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

Model Number LCB053

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

The user facility reported that their celerity 20 steam process challenge device biological indicator was dry following a processing cycle.The instrument subject of the load was reprocessed prior to use resulting in a procedure delay.

Manufacturer Narrative

The user facility could not confirm which of the two lot numbers was used at the time of the reported event.Retain testing was performed on the lot numbers subject of the reported event; no issues were noted.The dhrs for the subject lots were reviewed and no abnormalities were found.The reported event may be attributed to inadvertent damage of the biological indicator by user facility personnel.The celerity 20 steam process challenge device bi instructions for use state "before use, examine the bi to ensure that the media-filled cap is not fully seated on the top of the vial and that the foil seal on the cap remains intact.Without removing the cap, examine the bi for evidence of media in the vial.If media is detected in the vial, the seal has been compromised, do not use the bi." the user facility was provided with replacement product.A steris account manager counseled user facility on the proper use and handling of bis, specifically, not to use if no media is present.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: 16098629
• MDR Text Key: 308540912
• Report Number: 3004080920-2023-00001
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995161566
• UDI-Public: 10724995161566
• 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: 01/04/2023

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: LCB053
• Device Catalogue Number: LCB053
• Device Lot Number: 20240408, 20240229
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 01/04/2023
• Date Device Manufactured: 09/22/2022
• 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