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

Model Number LCB044

Device Problem Leak/Splash (1354)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

The user facility reported via medwatch report mw5114138 that there was no media in the cap for biological testing.No report of injury or procedure delay.

Manufacturer Narrative

The report did not identify the name or location of the user facility of the device in question therefore, additional information could not be obtained.To-date we have not been informed of this event directly from the user facility.The reported event may be attributed to inadvertent damage of the biological indicator by user facility personnel.The celerity 20 hp 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 device history record was reviewed and confirmed that the device was manufactured to specification.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: 16358303
• MDR Text Key: 309598639
• Report Number: 3004080920-2023-00002
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10724995154230
• UDI-Public: 10724995154230
• Combination Product (y/n): N
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LCB044
• Device Catalogue Number: LCB044
• Device Lot Number: 20230805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2022
• 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