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

Lot Number 171018G

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

Patient Problem Burn(s) (1757)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

The verify v24 self-contained biological indicator (scbi) is a single use device intended for routine monitoring of vaporized hydrogen peroxide sterilization cycles.Each indicator is completely self-contained, and includes a glass ampoule of growth media within a plastic vial.The growth media is not hazardous.The employee stated that when she went to retrieve the biological indicator from the instrument pack within the sterilizer, the glass media ampoule was outside the plastic vial.Without wearing proper ppe, specifically gloves, the employee removed the instrument pack from the sterilizer and obtained the burn.As the glass media ampoule was outside the plastic vial, this would indicate the biological indicator sustained damage while in the instrument pack and/or sterilizer.Following the reported event the v-pro max sterilizer was inspected and the unit was found to be operating properly.No issues were noted.The sterilizer was tested and returned to service.No additional issues have been reported.The verify scbi instructions for use state: "caution: in some instances residual hydrogen peroxide may be trapped within the media of a damaged ampoule.Should this occur avoid direct contact with the scbi and its contents.Caution: always wear gloves when handling the scbi." the v-pro max sterilizer operator manual states (pp.1-2), "any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide." the operator manual states (pp.6-14), "steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." due to the glass media ampoule being outside the plastic vial, the reported event can be attributed to mishandling and/or misuse of the scbi.Steris offered in-service training on the proper use and handling of the scbi.

Event Description

The user facility reported that following a completed v-pro max sterilization cycle, an employee removed an instrument pack and obtained a burn.The employee rinsed her hands under water and went to the facility's occupational health.No procedure delays or cancellations were reported.

• 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: 6312578
• MDR Text Key: 67237367
• Report Number: 3004080920-2017-00002
• 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: 171018G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• 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
• Patient Outcome(s): Other