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

Lot Number 160607B

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Test Result (2695)

Event Date 01/06/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris account manager completed in-service training with the user facility staff about proper use of the verify vhp scbi.The dhr for the lot number subject of the reported event was reviewed and no issues were noted.Steris will perform retain testing on the lot number subject of the reported event.The investigation of this event is currently in process.A follow-up mdr will be submitted once additional information becomes available.

Event Description

The user facility reported three positive verify vhp scbis after processing in a third-party sterilizer.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

The user facility confirmed that all instruments present during the time of the reported event were reprocessed before use.The user facility stated that the positive bi's were being obtained from the same incubator.The third party sterilizer was stated to be operating properly with no issues noted.The user facility replaced the incubator and no additional issues have been reported.Steris performed retain testing on the lot number subject of the reported event and no issues were noted.

• Brand Name: VERIFY VHP 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: 5413647
• MDR Text Key: 37571675
• Report Number: 3004080920-2016-00005
• 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,Followup
• Report Date: 02/05/2016

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: 160607B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• 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