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

Lot Number 150228B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/14/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee removed a damaged biological indicator from the chamber and their fingers turned white.The employee washed their hands with soap and water and returned to work.No additional medical treatment was sought or administered.

Manufacturer Narrative

A steris service technician inspected the v-pro max sterilizer in which the biological indicator was removed from and found it to be operating properly; no issues were noted and the sterilizer was returned to service.The employee was not wearing gloves at the time of the reported event.The 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." the instruments present in the sterilizer during the time of the reported event were not reprocessed before use in patient procedures.The instructions for use state: "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." a chemical indicator was present in the chamber during the time of the reported event.The chemical indicator evidenced passing results.Steris performed in-service training on the proper use and handling of the scbi.The cycle tapes from the v-pro max were reviewed and evidenced passing results; no issues were noted.The dhr for the lot number subject of the reported event was reviewed and no issues were noted.Retains for the lot were tested and no issues were noted.

• 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: 4243372
• MDR Text Key: 21834994
• Report Number: 3004080920-2014-00013
• 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: 11/11/2014

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: 150228B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/11/2014
• 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