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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/03/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after a sterilization cycle was completed, the volume of media contained in the verify dual species self-contained biological indicator appeared low.The facility stated the scbi may have cracked during processing and liquid from the scbi may have contacted instruments present in the load.Instruments included in the load were not reprocessed before use in a patient procedure.No injuries or adverse effects were reported following the event.

Manufacturer Narrative

After the sterilization cycle was completed, the scbi was removed from the load for incubation.At this time, the facility's technician noticed the scbi contained a low volume of liquid.The technician stated the scbi color appeared normal, however the scbi may have cracked during the cycle and leaked onto instruments present in the load.The technician then observed the instruments included in the load and found the instruments appeared dry.Instruments in the sterilization cycle were then used during a patient procedure.The facility contacted steris to inquire as to whether or not the instruments should have been used without reprocessing.A steris quality manager contacted the facility following the event in order to obtain additional information.The facility stated that the ci included in the load evidenced passing results; however steris informed the facility that to ensure sterility instruments in the load should be re-cleaned and reprocessed before use in a patient procedure.A steris account manager will visit the facility to perform a full in-service on the use of biological products.No further issues have been reported.

• Brand Name: VERIFY DUAL SPECIES 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: 3787146
• MDR Text Key: 4360560
• Report Number: 3004080920-2014-00007
• 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: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/02/2014
• 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