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

Lot Number 171115H

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that instruments present with the reported bi were recalled and reprocessed prior to use; a procedure delay occurred due to the reprocessing.The user facility stated they process a high volume of instruments and allow for the release of instruments prior to the 24-hour bi incubation period.This does not align with the v24 verify scbi instructions for use.The instructions for use state: "shake activated scbi vial using a back and forth motion for 10 seconds to allow the media to make effective contact with the indicator organism.Incubate at 55-60°c for 24 hours.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." a steris service technician arrived onsite to inspect the user facility's sterilizer.The technician inspected the sterilizer and found it to be operating properly.No issues were noted and the sterilizer was returned to service.The dhr was reviewed for the subject lot and no issues were noted.Retain testing was conducted on the bi lot subject of the reported event and no issues were noted.Steris offered in-service training on the proper use and handling of the bi, specifically the importance of the 24-hour incubation period, however the user facility declined.

Event Description

The user facility reported a positive biological indicator (bi) result.

• 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: 6310367
• MDR Text Key: 67209144
• Report Number: 3004080920-2017-00001
• 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: 02/08/2017

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: 171115H
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 02/08/2017
• 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