MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Lot Number 150228G

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/19/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after incubation of their biological indicator a positive result was identified.The user facility reported one instrument was used in a patient procedure prior to evaluating the results of the biological indicator.

Manufacturer Narrative

A steris service technician inspected the v-pro max sterilizer in which the biological indicator was processed in and found it to be operating properly.No issues were noted with the unit and it was returned to service.No additional issues have been reported.The verify scbi instructions for use state: in the process indicator did not change correctly, vaporized hydrogen peroxide did not come into contact with the scbi.Follow departmental procedures for reporting sterilization failures.Do not use items processed in the load.These items must be reprocessed.The instructions for use further states: observe the scbis at 24 hours of incubation.The scbi is positive for growth if it demonstrates turbidity and/or a color change from orange to yellow.Conditions for sterilization were not achieved.Follow departmental procedures for reporting sterilization failures.Steris conducted retain testing on the lot number subject of the reported event and no issues were noted.Steris will offer in-service training on the proper use and handling of the biological indicator.

Manufacturer Narrative

Steris' offer of in-service training was accepted by the user facility.Steris performed in-service training on the proper use and handling of the bi.

• Brand Name: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
• 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: 4347099
• MDR Text Key: 19349881
• Report Number: 3004080920-2014-00016
• 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,Followup
• Report Date: 12/19/2014

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: 150228G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• 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
• Patient Outcome(s): Other