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

Lot Number 150403C

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 02/13/2015

Event Type  No Answer Provided  

Event Description

The user facility reported two positive bi results.The user facility declined to provide additional information regarding the event; specifically if instruments were reprocessed before use in patient procedures and if procedural delays or cancellations occurred as a result of the positive bis.

Manufacturer Narrative

The sterilizer subject of the reported event is not manufactured by steris.The user facility stated that the sterilizer was found to be operating properly with no issues noted.Retain testing was conducted for the bi lot subject of the reported event and no issues were noted.The dhr was reviewed and no issues were noted.The technician reviewed proper use and handling of the bi with the user facility, specifically the importance of checking the cap of the bi prior to and after processing to ensure proper placement.The instructions for use states: "before use, examine biological indicator vial to ensure cap bottom does not extend beyond top arrow on vial label and cap freely rotates." the instructions for use further states: "the scbi is properly activated if the cap is pushed down to the second bar on the vial label and the culture media is released from the crushed ampoule.".

• 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: 4614417
• MDR Text Key: 22250479
• Report Number: 3004080920-2015-00009
• 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: 03/18/2015

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: 150403C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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