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

Device Problem False Positive Result (1227)

Patient Problem Test Result (2695)

Event Date 07/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

All instruments involved during a load experiencing a positive result were properly reprocessed.No instruments relating to the reported event have been used in patient procedures.The sterilizer subject of the reported event is not manufactured or serviced by steris.The user facility was not able to provide the lot numbers from the verify scbi's, therefore retain testing was not able to be performed.Steris has made multiple attempts to confirm whether any procedural delays or cancellations resulted from the reported event, however the user facility has not responded.A follow-up mdr will be filed should additional information be obtained.

Event Description

The user facility reported positive verify scbi results.

Manufacturer Narrative

During follow up regarding the reported event, additional information was identified.The user facility notified steris that no procedure delay or cancellation occurred as a result of the reported event.The steris account manager performed in-service training with the user facility on 8/29/2016 regarding the proper use and operation of the verify scbis.

• 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: 5908358
• MDR Text Key: 53303594
• Report Number: 3004080920-2016-00013
• 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: 08/26/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• 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