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

Lot Number 160728H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The dhr for the biological indicator lot number subject of the reported event was reviewed and no issues were noted.Retain testing on the biological indicator lot number subject of the reported event were completed and no issues were noted.The user facility accepted in-service training on the proper use and handling of the scbi.The steris sales representative stated that the reported event is attributed to misuse and handling of the scbi.The instructions for use states: observe the scbis at 24 hours (up to 7 days) of incubation.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.

Event Description

The user facility reported that their biological indicator did not evidence passing results after processing in a third party sterilizer.Instruments present were subsequently utilized in patient procedures.The user facility stated they will follow their protocol for patient notification.

• 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: 5564584
• MDR Text Key: 42334094
• Report Number: 3004080920-2016-00007
• 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: 04/08/2016

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: 160728H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/08/2016
• 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