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

Lot Number 150403B

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 02/06/2015

Event Type  No Answer Provided  

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.

Manufacturer Narrative

No procedural delays or cancellations were reported.The user facility followed their hospital protocol in notifying the patients that were involved in the procedures.No adverse effects have been reported.A steris service technician inspected the v-pro sterilizer in which the positive bi subject of the reported event was run and found it to be operating properly.Additionally, the technician reviewed the cycle tapes 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.A steris account manager visited the facility and noted that the bis were being stored on top of the v-pro unit.Additionally, the relative humidity in the room was between 2-7%.The v24 self-contained biological indicator instructions for use state bi storage conditions requirements to be 21-25 degrees celsius and relative humidity of 40-60%.Steris provided in-service to the user facility on the proper storage of bis.The user facility is now storing bis in a separate room with conditions that meet the bi instructions for use.No additional positive bis have been obtained since the move.

• 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: 4575394
• MDR Text Key: 20123406
• Report Number: 3004080920-2015-00008
• 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: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 150403B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2015
• 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