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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 03/04/2015

Event Type  No Answer Provided  

Event Description

The user facility reported a positive bi from their v-pro max sterilizer.Instruments were not reprocessed prior to use in patient procedure.No report of procedural delay or cancellation.

Manufacturer Narrative

The user facility declined to provide information regarding patient notification.The instructions for use for lcb022 states, "follow departmental procedures for investigation of sterility assurance failures." no adverse effects have been reported since the reported event.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; unable to duplicate the reported event.Additionally, the technician reviewed the cycle tapes and the inner and outer cis which evidenced passing results.The dhr of the lot number subject of the reported event was reviewed; no issues were noted.Additionally, retains of the lot were tested, and no issues were noted.The user facility reported hospital personnel were improperly activating bis, specifically tapping them on the countertop.The bi sustained damage from contact with the countertop and resulted in the reported event.The instructions for use states, "shake activated scbi vial using a back and forth motion for 10 seconds to allow the media to make effective contact with the indicator organism." steris has conducted in-service training with the user facility since the reported event.

• Brand Name: 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: 4654005
• MDR Text Key: 5600791
• Report Number: 3004080920-2015-00011
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/02/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/02/2015
• 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
• Patient Outcome(s): Other