BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRING OUTSIDE OF INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INSTRUMENT IS LEAKING WASTE. ADDITIONALLY, ON 2020-06-19 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IS INSTRUMENT ASSURITY LINC ENABLED? (Y/N) NO CUSTOMER PROBLEM: INSTRUMENT LEAKING WASTE STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CTS TO TROUBLESHOOT NEXT STEPS (IF NECESSARY): FORWARD CASE TO CTS FOR TROUBLESHOOTING ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES, WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO, LEAK (IF YES EXPLAIN)? YES. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? UNKNOWN. FOLLOW UP REQUIRED (Y/N)? UNKNOWN. LIST OF PARTS SHIPPED (INCLUDE FOC): UNKNOWN. RMA REQUIRED (Y/N)? UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRING OUTSIDE OF INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INSTRUMENT IS LEAKING WASTE. ADDITIONALLY, ON 2020-06-19 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IS INSTRUMENT ASSURITY LINC ENABLED? (Y/N) NO. CUSTOMER PROBLEM: INSTRUMENT LEAKING WASTE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CTS TO TROUBLESHOOT NEXT STEPS (IF NECESSARY): FORWARD CASE TO CTS FOR TROUBLESHOOTING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? YES. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WHAT WAS THE FLUID THAT LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? UNKNOWN. FOLLOW UP REQUIRED (Y/N)? UNKNOWN. LIST OF PARTS SHIPPED (INCLUDE FOC): UNKNOWN. RMA REQUIRED (Y/N)? UNKNOWN.

Additional Manufacturer Narrative

H.6. INVESTIGATION: PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE SPA IS LEAKING WASTE. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 6 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER BD CUSTOMER SUPPORT THE CUSTOMER SAID THAT THE PROBLEM IS RESOLVED. CUSTOMER DECLINED TO GIVE ANY DETAILS ABOUT THE SOLUTION OR TROUBLESHOOTING DETAILS. THERE WAS NO EXPOSURE THE HAZARDOUS MATERIALS. THERE WAS NO PHYSICAL HARM TO THE CUSTOMER. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER: N/A. INSTALL DATE: 08/08/2017. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: SPA LEAKING. PROBLEM DESCRIPTION: LEAKING. CAUSE: UNDETERMINED. WORK PERFORMED: NONE. SOLUTION: UNDETERMINED. RETURNED SAMPLE EVALUATION: NO REPORTED DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR PART NUMBER: 647205 AND SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? ¿YES ¿NO. HAZARD ID: 3.1.29. HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL:ALARP. MITIGATION(S) SUFFICIENT ¿YES ¿NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS UNDETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS UNCONFIRMED H3 OTHER TEXT : SEE H.10.