MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Lot Number 150228D

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

Event Date 10/03/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after the 24 hour incubation period of their biological indicator, positive growth was identified.No procedural delays or cancellations were reported.

Manufacturer Narrative

A battery was identified to be unwrapped on the clean side indicating that it could have potentially been used during a patient procedure.Four patient procedures were identified where the battery could have been used.The user facility followed their hospital protocol and the doctors involved in the four patient procedures were notified.No adverse affects have been reported.A steris service technician inspected the v-pro sterilizers in which the biological indicators obtained positive growth from and found them to be operating properly.No issues were noted and the sterilizers were returned to service.No additional issues have been reported.The dhr of the lot number subject of the reported event was reviewed; no issues were noted.Retains of the lot were tested and no issues were noted.The v24 self-contained biological indicator instructions for use state: "the scbi is positive for growth if it demonstrates turbidity and/or a color change from orange to yellow.Conditions for sterilization were not achieved.Follow departmental procedures for reporting sterilization failures." steris performed in-service training on the proper use and handling of biological indicators.

• Brand Name: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
• 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: 4218028
• MDR Text Key: 17994801
• Report Number: 3004080920-2014-00012
• 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: 10/31/2014

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: 150228D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/31/2014
• 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
• Patient Outcome(s): Other