BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD FACSCANTO¿ II FLOW CYTOMETER WAS LEAKING INTERNALLY. THE CUSTOMER DISCONTINUED USE AND REQUESTED SERVICE. DURING TROUBLESHOOTING, THE FIELD SERVICE ENGINEER (FSE) WAS SPRAYED WITH BIOHAZARDOUS WASTE IN THE EYE. AT THE TIME OF THE INCIDENT, THE FSE WAS WEARING THE PROPER PERSON PROTECTIVE EQUIPMENT (PPE). NO ADVERSE EFFECTS WERE REPORTED BY THE FSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT INSTRUMENT IS LEAKING FROM INSIDE THE INSTRUMENT. CUSTOMER CONFIRMED THERE IS NO ERROR OCCUR. CUSTOMER DID NOT KNOW THE ROOT CAUSE OF THE LEAKING AND CUSTOMER REQUESTING TO DISPATCH THIS CASE TO FSE FOR FURTHER INVESTIGATION.