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

Lot Number 160520H

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/08/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated that the chemical indicator present evidenced passing results.A steris service technician inspected the v-pro max and found the sterilizer to be operating properly.The technician reviewed the cycle print out subject of the reported event and no issues were noted; the technician returned the sterilizer to service.The biological indicator present during the time of the reported event was a steris bi.The dhr for the bi lot number was reviewed and no issues were noted.Steris performed in-service training on the proper use and operation of the sterilizer and biological indicator.

Event Description

The user facility reported that after a completed v-pro max sterilization cycle the biological indicator present did not evidence passing results.Instruments present were subsequently utilized in patient procedure(s).The user facility declined to provide information regarding their protocol of patient notification.

• 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: 5362964
• MDR Text Key: 35747775
• Report Number: 3004080920-2016-00002
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 160520H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• 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): Hospitalization