MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Lot Number 150723

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

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

Event Date 01/07/2015

Event Type  No Answer Provided  

Event Description

The user facility reported they obtained a failed biological indicator result.No report of injuries or procedural cancellations.All instruments in the cycle with the failed bi were reprocessed.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the v-pro max sterilizer, and was unable to identify any issue with the sterilizer.The technician performed a leak test and ran a non lumen cycle.The cycle ran successfully; never alarming or showing any signs of improper sterilization.The technician confirmed the unit to be operating according to specification.Steris performed retain testing on the lot number subject of the reported event and was unable to duplicate the reported issue.The technician noted that storage conditions for the bis were at 68°f, below the acceptable range indicated by steris.The instructions for use for the verify v24 self-contained biological indicator states, "prior to use, verify v24 self-contained biological indicators should be stored at 70-77°f (21-25°c), 40 - 60 % relative humidity (rh) away from direct light." the customer informed the technician that the user facility had not always completely dried their instruments before use.Page 10 of the v-pro max operator manual states, "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle.".

• Brand Name: VERIFY V24 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: 4491470
• MDR Text Key: 18545495
• Report Number: 3004080920-2015-00004
• 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: 02/06/2015

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
• Device Lot Number: 150723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA 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