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

Lot Number 171221L

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility stated an instrument present in the cycle with a failed biological indicator (bi), was used in a patient procedure.No injuries or medical treatment was required.The other instruments present were reprocessed before use in patient procedures.A steris service technician inspected the v-pro max sterilizer and found the unit to be operating properly; no issues were noted.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 specifications.As the v-pro max cycle parameters were achieved, the failure is attributed to user mishandling of the scbi.Steris performed in-service training on the proper use and handling of the verify v24i scbi.No additional issues have been reported.

Event Description

The user facility reported their verify v24i self-contained biological indicator (scbi) evidenced positive results after processing in a v-pro max sterilizer.

• 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: 6472915
• MDR Text Key: 72588240
• Report Number: 3004080920-2017-00005
• 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: 04/07/2017

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: 171221L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/07/2017
• 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