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

Device Problem Device Expiration Issue (1216)

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

Event Date 06/08/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The facility stated the v-pro unit and cycle tapes evidenced passing results in all instances where expired biological indicators were included in the sterilization cycles.Following the event, the customer contacted their steris account manager to inquire about the risk of using expired biological indicators.The steris account manager reiterated the verify self-contained biological indicator instructions for use to the customer.The instructions for use state, "do not use beyond the expiration date located on the verify self-contained biological indicator for vaporized sterilization processes packaging and labeling".The customer was advised to follow their hospital protocol regarding notifying patients of their use of expired indicators.Following the event, the steris account manager performed in-service training regarding the proper use and operation of the verify scbi.

Event Description

The user facility reported they used expired biological indicators in v-pro sterilization cycles.

• 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: 5772761
• MDR Text Key: 48874488
• Report Number: 3004080920-2016-00011
• 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: 07/06/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/06/2016
• 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