BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO. LEAK CHECKLIST FROM CASE 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE?: NO SPRAY OF LIQUID. IT WAS REPORTED THAT THE WASH STATION WAS OVERFLOWING. IS INSTRUMENT ASSURITY LINC ENABLED?: NO CUSTOMER PROBLEM: FROM E-MAIL: WASH STATION OVERFLOWING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE. NEXT STEPS (IF NECESSARY): DISPATCH 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)? WASH STATION OVERFLOWING 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT?: YES. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION?: YES. 3. WHAT WAS THE FLUID THAT LEAKED?: WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE?: WASH STATION. 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)?: N. FOLLOW UP REQUIRED (Y/N)?: Y. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)?: N/A.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07OCT2020 TO DATE 07OCT2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07OCT2020 TO DATE 07OCT2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPAIR/TROUBLESHOOTING PERFORMED: CLEARED CLOG FROM QUICK DISCONNECT FITTING ON WASH STATION. FLUSHED FLUIDICS AND VERIFIED INSTRUMENT PERFORMANCE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4) INSTALL DATE: 25SEP2009 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING, PROBLEM DESCRIPTION: WASH STATION PUMP CLOGGED, CAUSE: CLOGGED WASH PUMP,, WORK PERFORMED: CLEANED PUMP, SOLUTION: CLEANED PUMP. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0015 AND PN647205 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 COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07OCT2020 TO DATE 07OCT2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07OCT2020 TO DATE 07OCT2021 (ROLLING 12 MONTHS) COMPLAINT DATA ATTACHED INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPAIR/TROUBLESHOOTING PERFORMED: CLEARED CLOG FROM QUICK DISCONNECT FITTING ON WASH STATION. FLUSHED FLUIDICS AND VERIFIED INSTRUMENT PERFORMANCE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: 25SEP2009 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING PROBLEM DESCRIPTION: WASH STATION PUMP CLOGGED CAUSE: CLOGGED WASH PUMP WORK PERFORMED: CLEANED PUMP SOLUTION: CLEANED PUMP RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0015 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 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 COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO LEAK CHECKLIST FROM CASE 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO SPRAY OF LIQUID. IT WAS REPORTED THAT THE WASH STATION WAS OVERFLOWING. IS INSTRUMENT ASSURITY LINC ENABLED? N CUSTOMER PROBLEM: FROM E-MAIL: WASH STATION OVERFLOWING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N WAS THERE ANY INJURY OR POTENTIAL INJURY? N LEAK (IF YES EXPLAIN)? WASH STATION OVERFLOWING 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? Y 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y 3. WHAT WAS THE FLUID THAT LEAKED? WASTE 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH STATION 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N SOFTWARE VERSION? UNKNOWN RESOLUTION ACHIEVED (Y/N)? N FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A RMA REQUIRED (Y/N)? N/A.

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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO. LEAK CHECKLIST FROM CASE 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO SPRAY OF LIQUID. IT WAS REPORTED THAT THE WASH STATION WAS OVERFLOWING. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: FROM E-MAIL: WASH STATION OVERFLOWING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE. NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? WASH STATION OVERFLOWING. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? Y. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y. 3. WHAT WAS THE FLUID THAT LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH STATION. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A.