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

Lot Number 150228G

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that instruments were used in patient procedures after positive biological indicators were obtained.No injuries were reported however, procedural delays were reported.

Manufacturer Narrative

Retains were tested and the dhrs were reviewed for the lot numbers subject of the reported event and no issues were noted.The user facility contacted a steris technician about their v-pro max sterilizer in which the bi's were processed in.The steris technician advised user facility personnel to perform a leak test and provide sterilizer specifications; no issues were noted.The sterilizer was returned to service and no additional issues have been reported.Steris will evaluate the v-pro max sterilizer subject of the reported event.Steris performed in-service training on the proper use and handling of the scbi.

• 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: 4484802
• MDR Text Key: 18002112
• Report Number: 3004080920-2015-00003
• 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: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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
• Date Manufacturer Received: 01/05/2015
• 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