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

Lot Number 171221C

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Operates Differently Than Expected (2913)

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

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

A chemical indicator was present during the time of the reported event which evidenced passing results.No procedure delays or cancellations were reported.The user facility reported that instruments present in the cycle with the failed biological indicator (bi) were utilized in patient procedures.The facility followed their protocol for patient notification.No adverse effects were reported as a result.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 user facility's spd manager stated that the cap on the bi may not have been properly closed/activated following the sterilization cycle.The reported event is attributed to misuse and handing of the bi by user facility personnel.The instructions for use state, "to seal and activate, place scbi into the specially designed cavity of verify self-contained biological indicator hp activator** handle.Close the activator handle.Gripping seat the cap and crush the media ampoule within the scbi to release the media".A steris account representative scheduled in-service training on the proper product usage specifically using the proper technique to close and activate the scbis which was performed the week of june 5th, 2017.No additional issues have been reported.

Event Description

The user facility reported their self-contained biological indicator (scbi) evidenced positives results.

• 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: 6665172
• MDR Text Key: 78457575
• Report Number: 3004080920-2017-00006
• 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: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 171221C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• 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