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

Lot Number 150228G

Device Problem Output Problem (3005)

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

Event Date 11/05/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed v-pro max sterilization cycle, the biological indicator evidenced failing results.Instruments present in the cycle were subsequently used in patient procedures.Doctors were notified of the reported event and contacted patients per their hospital protocol; no adverse effects have been reported.No procedural delays or cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the v-pro max sterilizer subject of the reported event and found the sterilizer to be operating properly and to specifications.Retain testing and dhr review of the lot subject of the reported event was conducted and no issues were noted.The user facility sent lot samples back to steris for evaluation.Steris found no issues with the indicators.The instructions for use states: the scbi is positive for growth if it demonstrates turbidity and/or a color change from orange to yellow.Conditions for sterilization were not achieved.Follow departmental procedures for reporting sterilization failures.The instructions for use states: if the process indicator did not change correctly, 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 offered in-service training on the proper use and handling of the indicator however, the user facility declined.

• 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: 4297719
• MDR Text Key: 5194474
• Report Number: 3004080920-2014-00015
• 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: 12/04/2014

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: 150228G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/04/2014
• 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