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

Lot Number 171018A

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

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

Event Date 09/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated instruments present in cycles with failed bi results were used in patient procedures.The facility followed their protocol for patient notification.No adverse effects were reported as a result.The user facility performed an investigation of the incident and identified that the cause of the reported event was due to improper usage of the verify scbis.The user facility performed training to ensure instruments within cycles with failed bi results are not used in patient procedures.The verify scbi 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." the user facility stated that the steris vpro sterilizer was operating according to specification.Steris will perform in-service training on the proper use and operation of the verify scbis with the user facility.

Event Description

The user facility reported their verify scbis were evidencing positive results.

• 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: 6177611
• MDR Text Key: 62544357
• Report Number: 3004080920-2016-00017
• 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: 12/15/2016

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: 171018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/15/2016
• 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