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

Lot Number 140601G

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/27/2013

Event Type  No Answer Provided  

Event Description

The user facility reported that instruments were used in a patient procedure after a positive bi was obtained.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information is available.

Manufacturer Narrative

A steris clinical education specialist went onsite and noted the following: after a processing cycle only a biological indicator (bi) was present in the peel pouch and not a chemical indicator (ci).A chemical indicator should have been present as stated in the instructions for use.When the peel pouch was removed it was observed to be improperly sealed.Facility's lot and expiration data log book for bi's and ci's is not up to date.Improper loading of sterilizer trays.In addition, the clinician observed cleaning practices of instruments before placement in the peel pouches for sterilization.User facility personnel were wiping instruments with alcohol and drying them without a rinse process prior to placement in the v-pro max sterilizer.The clinician conducted in-service training with user facility personnel on: proper loading techniques for the sterilizer, visually reading the indicator(s) properly, weight limits of the sterilizer trays, importance of dried instruments/devices before being placed in peel pouch before processing, use of material not compatible with the v-pro max sterilizer.Retain testing was conducted on the bi lot number subject of the reported event and evidenced no abnormalities were observed.The dhr was reviewed and confirmed the lot was manufactured to specification.A steris service technician inspected the v-pro max sterilizer subject of the reported event and found it to be operating properly; no issues were noted.As a proactive approach the technician replaced sv6 and sv8.The sterilizer was returned to service.

• Brand Name: VERIFY V24 SCBI
• Type of Device: PROCESS INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3601650
• MDR Text Key: 17389553
• Report Number: 3004080920-2014-00002
• 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,Followup
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 140601G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• 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