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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION CELERITY 20 HP BIOLOGICAL INDICATOR
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STERIS CORPORATION CELERITY 20 HP BIOLOGICAL INDICATOR Back to Search Results
Lot Number 20211007
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
Event Type  malfunction  
Manufacturer Narrative
The user facility reported that four biological indicators contained no media after processing four separate cycles.The reported event may be attributed to inadvertent damage of the biological indicators 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." steris inspected the retains of the lot number subject of this event and confirmed there was no evidence of damage, and all retains contained media.Additionally, the device history record was reviewed, and no abnormalities were found.No additional issues have been reported.
 
Event Description
The user facility reported to anvisa that four of their celerity 20 hp biological indicators (bis) were dry following processed cycles.
 
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Brand Name
CELERITY 20 HP BIOLOGICAL INDICATOR
Type of Device
CELERITY 20 HP BIOLOGICAL INDICATOR
Manufacturer (Section D)
STERIS CORPORATION
9325 pinecone dr
mentor OH 44060
MDR Report Key12564308
MDR Text Key283593962
Report Number3004080920-2021-00001
Device Sequence Number1
Product Code FRC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 10/01/2021
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 Lot Number20211007
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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