MAUDE Adverse Event Report: STERIS CORPORATION CELERITY 20 STEAM PROCESS CHALLENGE DEVICE; BIOLOGICAL INDICATOR

Model Number LCB053

Device Problem Use of Device Problem (1670)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The user facility reported that their celerity 20 steam process challenge device contained a dry biological indicator which was "affecting the caseloads and patient care" for the facility.

Manufacturer Narrative

Retain testing was performed on the lot number subject of the reported event; no issues were noted.The dhr for the subject lot was reviewed and no abnormalities were found.The reported event may be attributed to inadvertent damage of the biological indicator prior to use by user facility personnel.The celerity 20 steam process challenge device bi instructions for use state "before use, examine the pcd to ensure that the foil and seal are intact.Examine the integrator through the plastic, to ensure the pcd has not been used previously.Do not use the celerity 20 steam pcd if the seal has been broken and the foil is not intact." a follow-up will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: CELERITY 20 STEAM PROCESS CHALLENGE DEVICE
• 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: 16645856
• MDR Text Key: 312499400
• Report Number: 3004080920-2023-00003
• 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: 03/30/2023

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: LCB053
• Device Catalogue Number: LCB053
• Device Lot Number: 20240514
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/30/2023
• Date Device Manufactured: 12/07/2022
• 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