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

Lot Number 140101B

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2013

Event Type  No Answer Provided  

Event Description

The user facility reported that instruments were used in a patient procedure after a positive bi was obtained.No injuries or adverse effects were reported.No procedural delays or cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the v-pro 1 plus sterilizer and found it to be operating properly; no issues were noted.The chemical indicator (ci) present during the time of the reported event evidenced passing results.The cycle print out subject of the reported event evidenced the cycle completed successfully.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." steris is scheduled to perform in-service on the proper use and handling of the scbi in the month of february.

• Brand Name: VERIFY V24 SCBI
• Type of Device: PROCESS INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3610271
• MDR Text Key: 4089465
• Report Number: 3004080920-2014-00003
• 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: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 140101B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• 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