MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SCBI; BIOLOGICAL INDICATOR

Lot Number 161202A

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility has declined to provide any additional information regarding the reported event.As the user facility declined to provide information, steris is unable to confirm if instruments were present and if so were they reprocessed before use, report of injury or procedural delays or cancellations and if any issues with the capital equipment caused the scbi to fail.The user facility stated they do not have steris capital equipment therefore steris is unable to identify the sterilizer used during the time of the reported event.Steris is unable to determine if the event meets our reporting criteria due to the user facility declining to provide information regarding the event, therefore we are filing this report.

Event Description

The user facility reported that their verify scbi did not evidence passing results.

• Brand Name: VERIFY V24 SCBI
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5685966
• MDR Text Key: 46161966
• Report Number: 3004080920-2016-00010
• Device Sequence Number: 1
• Product Code: FRC
• 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: 05/27/2016

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: Other
• Device Lot Number: 161202A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: No
• 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