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

Lot Number 150130B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 08/20/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee received a chemical burn after removing a verify self-contained biological indicator processed in a sterrad® sterilizer.The employee visited the facility's er following the event and has since returned to normal work duties.No procedural delays/cancellations were reported.

Manufacturer Narrative

The user facility placed the scbi into a pouch for processing in a sterrad® sterilizer.The cycle completed successfully.Upon removal of the scbi from the pouch the employee felt moisture on her fingers along with a burning sensation.The employee inspected the scbi and identified a small crack in the scbi vial which caused media to leak onto her fingers.The verify v24 self-contained biological indicator instructions for use state, "safety related precautions - residual hydrogen peroxide may be trapped within the media if the scbi is damaged.Avoid direct contact with the scbi and its contents, as it may result in a hydrogen peroxide chemical burn." further, "if the ampoule is broken or any evidence of media leakage is observed do not remove the scbi from the packaging and/or touch the scbi.The test must be repeated using a fresh scbi." the employee reprocessed the instruments present in the load with a fresh scbi.The employee washed her hands for 15 minutes and visited the facility's er following the event.The employee stated the burn was minimal and did not state whether medical treatment was administered at the facility's er.The verify v24 scbi instructions for use state, "caution: always wear gloves when handling the scbi." the employee stated she was not wearing gloves at the time of the event and was aware that the instructions for use state to always wear gloves.Steris visually examined retain units from the lot subject of the event and did not identify any evidence of cracked or damaged vials.In addition, retain samples were placed in test sterilization cycles and did not evidence cracking upon removal from the sterilizer.Following the event, a steris account manager visited the facility and confirmed the facility is aware of the ppe requirements for handling scbis.No further issues have been reported.

• 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: 4099891
• MDR Text Key: 4696671
• Report Number: 3004080920-2014-00011
• 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: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 150130B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/18/2014
• 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