MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS; BIOLOGICAL INDICATOR

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 10/27/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician inspected the v-pro max sterilizer in which the positive bi subject of the reported event was run and found it to be operating properly.Additionally the technician inspected the cycle tapes and no issues were noted.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 that instruments present in a load with a positive bi were not recalled and reprocessed prior to use in patient procedures.No report or injury or procedural delay or cancellation.

Manufacturer Narrative

Steris has made multiple attempts to obtain additional event information however the user facility will not respond.As the user facility did not respond to our multiple follow-up, attempts steris is unable to perform retain testing as the lot number for the bi subject of the reported event has not been provided.

• 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: 5249596
• MDR Text Key: 32320906
• Report Number: 3004080920-2015-00014
• 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: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• 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