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

Lot Number 180201M

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

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

Event Date 06/03/2017

Event Type  malfunction  

Manufacturer Narrative

A chemical indicator was present during the time of the reported event which evidenced passing results.Indicator tape present on the outside of the instrument pack evidenced passing results.The user facility reported that instruments present in the cycle with the failed biological indicator were utilized in patient procedures.The user facility followed their protocol and no adverse effects were reported.Retain testing was performed on the lot number subject of the reported event'; no issues were noted.The dhr was reviewed and no abnormalities were found.The steris account manager reviewed the cycle print out for the v-pro max sterilizer that the bi was present in.The review of the print out confirmed the sterilization parameters were achieved.When the account manager was onsite, she observed that the incubator contained a biological indicator.The cap on the biological indicator present in the incubator was not properly activated/sealed.Due to the steris account managers observation of the incubated scbis, the reported event may be attributed to improper use and mishandling of the product.The instruction for use states: "to seal and activate, place scbi into the specially designed cavity of the verify self-contained biological indicator hp activator handle.Close the activator handle.Gripping the activator in one hand, squeeze the activator.This will seat the cap and crush the media ampule within the scbi to release the media.The scbi is properly activated if the cap is pushed down to the second bar on the vial label and the culture media is released from the crushed ampoule." "caution-always use the activator to crush the media ampoule as incorrect activation may lead to use injury." the steris account manager provided in-service training on (b)(4) 2017 regarding the proper use and handling of the scbi.

Event Description

The user facility reported their self-contained biological indicator (scbi) evidenced positive results following a completed v-pro max sterilization cycle.

• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6677553
• MDR Text Key: 78960423
• Report Number: 3004080920-2017-00007
• 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: 06/29/2017

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: 180201M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2017
• Initial Date FDA Received: 06/29/2017
• 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