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

Lot Number 20220827

Device Problem Leak/Splash (1354)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

The user facility reported to sfda that during activation they may spill their lcb048 celerity 20 steam biological indicator (bi).No report of injury.

Manufacturer Narrative

The bi media is water-based and non-toxic.The reported event may be attributed to improperly handling or activation of the biological indicator by user facility personnel.The celerity steam biological indicator instructions for use include the process for proper activation of the bi, "to activate the bi, twist the cap clockwise while holding the vial to close the bi cap.Transfer the media from the cap to the vial by holding the bi firmly by its cap and flicking the wrist once.The bi is properly activated when the cap is seated tightly on the vial and the media has come in contact with the spores on the bottom of the vial.The media in the bottom of the vial will be purple." steris reviewed the lot history record, and no abnormalities were found.Steris dealer, al-jeel, counseled user facility personnel on the proper handling and activation of the celerity steam bi.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: 14141546
• MDR Text Key: 289503791
• Report Number: 3004080920-2022-00002
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 04/19/2022

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 Lot Number: 20220827
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2022
• Initial Date FDA Received: 04/19/2022
• 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