BD FACS SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 SPAIII (337170 UPGRADED) AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE SPA IS CLOGGED, AND THE WASH TOWER IS OVERFLOWING. 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 5 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: THE INVESTIGATION WAS PERFORMED AND BASED ON THE FSE REPORT THE MINI WASH PN334297 WAS REPLACED TO CORRECT THE PROBLEM. SYSTEM PASSED ALL REQUIRED TESTS. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER # (B)(4). INSTALL DATE: 14AUG2009. DEFECTIVE PART NUMBER: 334297. WORK ORDER NOTES: SUBJECT / REPORTED: WASH TOWER CLOGGED/OVERFLOW. PROBLEM DESCRIPTION: WASH TOWER WAS CLOGGED. CAUSE: MINI WASTE PUMP WAS NOT WORKING. WORK PERFORMED: REPLACED MINI WASH PN334297. SOLUTION: REPLACE MINI WASH. RETURNED SAMPLE EVALUATION: THE DEFECTIVE MINI WASH IS OUT OF WARRANTY AND NOT NEEDED FOR FAILURE ANALYSIS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR PN650686, 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. O HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL:ALARP. NEW HAZARD. MITIGATION(S) SUFFICIENT? YES? NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT, THE ROOT CAUSE WAS THE DEFECTIVE MINI WASH PUMP CAUSED THE WASH TOWER TO OVERFLOW. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A LEAKAGE OF BIOHAZARD THAT WAS NOT CONTAINED WITHIN INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT AFTERHOURS, THE FACS SPA IS CLOGGED AND OVER FLOODED. 1. ARE THERE ANY FORMS THAT THE FSE WILL NEED TO FILL OUT PRIOR TO ACCESSING YOUR FACILITY? N. 2. ARE THERE ANY SCREENINGS, SUCH AS TEMPERATURE READING TAKEN ON SITE? N. 3. ARE THEY TESTING OR RUNNING ACTIVE C19 SAMPLES? N. IF YES, DESCRIBE ANY KNOWN DETAILS. 4. ARE THERE ANY DIRECTIVES THAT THE FSE MUST FOLLOW THAT ARE NOT NORMAL PROCEDURES? (SHOTS UP TO DATE, FLU SHOT, ETC.) N. ARE THERE SPECIAL PROTOCOLS FOR ENTRY POINTS, ACCESS, PARKING, ETC. N 5. IS THERE ANY PPE PROVIDED BY YOUR ORGANIZATION? IF SO WHAT? IF NOT, WHAT DO WE NEED TO PROVIDE? YES, LAB COAT & GLOVES. IF PROVIDED, DOCUMENT APPLICABLE PPE. IF REQUIRED, THEN DOCUMENT WHAT PPE BD NEEDS TO SUPPLY MASK. 6. IS YOUR LAB RUNNING ANY SAMPLES OUTSIDE OF A BIO SAFETY CABINET? YES ALL REQUIRED. 7. ARE THERE ANY KNOWN ACTIVE CASES OF C19 AT YOUR LOCATION? IF YES, DESCRIBE DETAILS. N. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: WASH TOWER NOT APSIRATING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CLEANED FILTER, NO CHANGE. UNABLE TO TROUBLESHOOT WITH CUSTOMER. 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? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? N/A. SOFTWARE VERSION? N/A. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED? N/A. WAS THERE A FLUIDIC LEAK OR SPILL? N/A. 1. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? N/A. 2. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? N/A. 3. WHAT WAS THE FLUID THAT LEAKED/SPILLED? N/A. 4. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) N. 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. ADDITIONALLY, ON 2020-05-29 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PERTAINING TO THE WASTE BEING MIXED WITH BLEACH OR DECONTAMINATE, THE TSR STATES, " THAT FLUID IS SHEATH FLUID ALONG WITH MINUTE TRACES OF BLOOD. THERE IS NO BLEACH INVOLVED, SINCE THIS OVERFLOW IS HAPPENING BEFORE THE WASTE CONTAINER IS INVOLVED. ADDITIONALLY, ON 2020-06-01 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IN REGARDS TO THE LEAK/OVERFLOW BEING CONTAINED IN THE INSTRUMENT, THE TSR STATES, "MORE THAN LIKELY THE OVERFLOW WAS NOT CONTAINED.

Additional Manufacturer Narrative

(B)(4). 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 THERE WAS A LEAKAGE OF BIOHAZARD THAT WAS NOT CONTAINED WITHIN INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT AFTER HOURS, THE FACS SPA IS CLOGGED AND OVER FLOODED. ARE THERE ANY FORMS THAT THE FSE WILL NEED TO FILL OUT PRIOR TO ACCESSING YOUR FACILITY? N. ARE THERE ANY SCREENINGS, SUCH AS TEMPERATURE READING TAKEN ON SITE? N. ARE THEY TESTING OR RUNNING ACTIVE C19 SAMPLES? N. IF YES, DESCRIBE ANY KNOWN DETAILS. ARE THERE ANY DIRECTIVES THAT THE FSE MUST FOLLOW THAT ARE NOT NORMAL PROCEDURES? (SHOTS UP TO DATE, FLU SHOT, ETC.) N. ARE THERE SPECIAL PROTOCOLS FOR ENTRY POINTS, ACCESS, PARKING, ETC. N IS THERE ANY PPE PROVIDED BY YOUR ORGANIZATION? IF SO WHAT? IF NOT, WHAT DO WE NEED TO PROVIDE? YES, LAB COAT & GLOVES. IF PROVIDED, DOCUMENT APPLICABLE PPE. IF REQUIRED, THEN DOCUMENT WHAT PPE BD NEEDS TO SUPPLY MASK. IS YOUR LAB RUNNING ANY SAMPLES OUTSIDE OF A BIO SAFETY CABINET? YES ALL REQUIRED. ARE THERE ANY KNOWN ACTIVE CASES OF C19 AT YOUR LOCATION? IF YES, DESCRIBE DETAILS. N. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: WASH TOWER NOT ASPIRATING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CLEANED FILTER, NO CHANGE. UNABLE TO TROUBLESHOOT WITH CUSTOMER. 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? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? N/A. SOFTWARE VERSION? N/A LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED? N/A. WAS THERE A FLUIDIC LEAK OR SPILL? N/A. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? N/A. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? N/A. WHAT WAS THE FLUID THAT LEAKED/SPILLED? N/A. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) N. 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. ADDITIONALLY, ON 2020-05-29, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PERTAINING TO THE WASTE BEING MIXED WITH BLEACH OR DECONTAMINATE, THE TSR STATES, " THAT FLUID IS SHEATH FLUID ALONG WITH MINUTE TRACES OF BLOOD. THERE IS NO BLEACH INVOLVED, SINCE THIS OVERFLOW IS HAPPENING BEFORE THE WASTE CONTAINER IS INVOLVED. ADDITIONALLY, ON 2020-06-01, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IN REGARDS TO THE LEAK/OVERFLOW BEING CONTAINED IN THE INSTRUMENT, THE TSR STATES, "MORE THAN LIKELY THE OVERFLOW WAS NOT CONTAINED.