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

Lot Number 171115D

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Investigation of this event is currently in process.A follow up mdr will be submitted when additional information is obtained.

Event Description

The user facility stated that their verify scbi did not evidence passing results after the completion of a sterilization cycle.No injury, procedure delay, or cancellation was reported.

Manufacturer Narrative

The user facility reported their verify scbi was not evidencing passing results after the completion of sterilization cycles in their steris v-pro max sterilizer.The sterilizer was removed from service.All instruments involved with the reported event were reprocessed before use in a patient procedure.Procedure delays occurred due to the reprocessing of instruments.Retain testing was performed on the lot number subject of the reported event; no issues were noted and the dhr evidenced the lot was manufactured to specification.A steris services technician arrived on-site, inspected the sterilizer subject of the reported event, and confirmed it to be operating according to specification.The user facility confirmed that no additional bi failures have occurred.Steris offered the user facility in-service training on the proper use and operation of the verify scbi and the steris v-pro max sterilizer, however the user facility declined the offer.

• 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: 6210649
• MDR Text Key: 63434814
• Report Number: 3004080920-2016-00018
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 12/28/2016

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: 171115D
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• 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