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

Lot Number 140601S

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  No Answer Provided  

Event Description

The user facility reported they received two positive biological indicator (bi) results.The bis had been placed inside of a v-pro max sterilizer along with a chemical indicator (ci) and instruments for sterile processing.The cis present in the loads evidenced passing results.Instruments included in the load with the first bi failure were recalled and reprocessed before use in a patient procedure.The second load contained a camera which was not recalled before use in a procedure.No injuries or adverse clinical effects were reported due to the event.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the v-pro max sterilizer and found the equipment operating to specification.No repairs were required.The reported event could not be duplicated.The cycle printouts subject of the reported event evidenced the cycles completed successfully.In addition, the cis present in the loads evidenced passing results.Steris conducted retain testing on the lot subject of the reported event; no abnormalities were noted.The dhr for the scbi lot subject of the reported event was reviewed and evidenced it was manufactured to specifications.V24 verify scbi instructions for use states: "if the process indicator did not change completely, 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." a steris account manager performed in-service training on the proper use and handling of the scbi.No further issues have been reported since the in-service was performed.

• 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: 3826533
• MDR Text Key: 4498581
• Report Number: 3004080920-2014-00008
• 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: 05/22/2014

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: 140601S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/22/2014
• 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