BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER ADDRESS: (B)(6). 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 DURING FLUIDIC START-UP ON A BD FACSCANTO II FLOW CYTOMETER, A LEAK WAS IDENTIFIED. IN AN ERRORT TO STOP THE LEAK, THE USER DISCONNECTED A TUBE AT THE WET CART WHILE NOT WEARING SAFETY GLASSES, RESULTING IN FLUID SPRAYING INTO THEIR EYES. ADDITIONAL INFORMATION OBTAINED: WHILE THERE WAS AN INITIAL LIQUID LEAK DUE TO A COMPONENT FAILURE, THE DEFECTIVE COMPONENT WAS NOT ASSOCIATED WITH THE ALLEGED ADVERSE EVENT OF THE LIQUID SPRAY IN THE EYES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: INSTRUMENT LEAKAGE 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT (BROKEN) SKIN? IF NO, STOP, NO FURTHER QUESTIONS REQUIRED. YES 2. PROVIDE THE FLUID THAT LEAKED OR SPLASHED OR SPRAYED: SHEATH 3. WHICH PART OF THE BODY WAS IN CONTACT WITH THE FLUID? (PLEASE DESCRIBE THEN GO TO QUESTION #4): EYE 4. WHAT PPE WAS BEING WORK? (PLEASE DESCRIBE) THE EYES WERE RISED INDEPENDENTLY, AND NO DISCOMFORT WAS REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04135. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE WAS DETERMINED TO BE A DAMAGED CHECK VALVE. AFTER REPLACING THE CHECK VALVE, THE ISSUE WAS RESOLVED. THE CUSTOMER REPORTED A COMPLAINT REGARDING INSTRUMENT LEAK OF SHEATH FLUID THAT CAME IN CONTACT WITH THE EYE. THE CUSTOMER WAS NOT WEARING THE NECESSARY PPE (PERSONAL PROTECTIVE AND HENCE RINSED THEIR EYES INDEPENDENTLY WITHOUT FURTHER ISSUE. NO FURTHER DISCOMFORT WAS REPORTED. DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING FLUIDIC START-UP ON A BD FACSCANTO II FLOW CYTOMETER, A LEAK WAS IDENTIFIED. IN AN ERRORT TO STOP THE LEAK, THE USER DISCONNECTED A TUBE AT THE WET CART WHILE NOT WEARING SAFETY GLASSES, RESULTING IN FLUID SPRAYING INTO THEIR EYES. ADDITIONAL INFORMATION OBTAINED: WHILE THERE WAS AN INITIAL LIQUID LEAK DUE TO A COMPONENT FAILURE, THE DEFECTIVE COMPONENT WAS NOT ASSOCIATED WITH THE ALLEGED ADVERSE EVENT OF THE LIQUID SPRAY IN THE EYES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: INSTRUMENT LEAKAGE. 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT (BROKEN) SKIN? IF NO, STOP, NO FURTHER QUESTIONS REQUIRED. YES. 2. PROVIDE THE FLUID THAT LEAKED OR SPLASHED OR SPRAYED: SHEATH. 3. WHICH PART OF THE BODY WAS IN CONTACT WITH THE FLUID? (PLEASE DESCRIBE THEN GO TO QUESTION #4): EYE. 4. WHAT PPE WAS BEING WORK? (PLEASE DESCRIBE) THE EYES WERE RISED INDEPENDENTLY, AND NO DISCOMFORT WAS REPORTED.