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

Lot Number 150723A

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

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

Event Date 02/17/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed sterilization cycle a biological indicator was incubated and evidenced positive results.Some items present in the sterilizer were not reprocessed before use in patient procedures.The facility declined to provide if patients were notified of this event.No adverse affects have been reported.

Manufacturer Narrative

The sterilizer was inspected by the facility's biomed and found it to be operating properly.The cycle tape was reviewed and no issues were noted.The sterilizer was returned to service and no additional issues have been reported.Retain testing was conducted and no issues were noted with the lot number subject of the reported event.The dhr was reviewed and no issues were noted.A steris account manager discussed the reported event with hospital personnel.A staff member advised they over crushed/activated the bi after sterilization, before the incubation process.The ampoule inside should be crushed/broken, so it can release the media.The outside vial should not be cracked.When the bi is over crushed/broken, it can cause the outside and inside vial to crack leading to a potentially positive result.The steris account manager performed in-service training on the proper use and handling of the scbi.The 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.".

• 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: 4614115
• MDR Text Key: 5654771
• Report Number: 3004080920-2015-00010
• 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: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 150723A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• 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