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

Lot Number 171115C

Device Problem Insufficient Information (3190)

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

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility stated instruments present in the cycle with a failed biological indicator (bi), were used in a patient procedure.The v-pro 60 cycle tape was reviewed and no issues were noted; the cycle completed successfully.Retain testing was performed on the lot number subject of the reported event; no issues were noted and the dhr evidenced the scbi lot was manufactured to specification.As the v-pro 60 cycle parameters were achieved as evidenced by the cycle printout, the failure is attributed to user mishandling of the scbi.Per the steris account manager, in-service training will be offered to the user facility on the proper use and handling of the verify v24 scbi.No additional issues have been reported.

Event Description

The user facility reported their verify v24 self-contained biological indicator (scbi) evidenced positive results after processing in a v-pro 60 sterilizer.

Manufacturer Narrative

The facility followed their protocol for patient notification.No adverse effects were reported as a result.Per steris account manager, in-service training was performed on (b)(6) on the proper use and operation of the sterilizer and biological indicator.

• 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: 6413244
• MDR Text Key: 70536499
• Report Number: 3004080920-2017-00004
• 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,Followup,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 171115C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• 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