BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. 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 BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MACHINE OVERFLOWS, PARTS ARE WORN. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? PER WO NOTES - NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO SPRAY; YES IT WAS UNDER PRESSURE. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? NA. WHAT PERSONAL PROTECTIVE EQUIPMENT WAS BEING USED DURING THE OCCURRENCE? GLOVES , GLASSES, GOWN, MASK. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO. WHAT IS THE CURRENT MEDICAL STATUS? NA.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: LEAK. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (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) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE LEAK WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THE LEAK WAS WASTE AND FLUIDS USED FOR THE INSTRUMENT OPERATIONS SUCH AS SHEATH, DI WATER AND LYSE. THERE WAS NO BODILY CONTACT OR HARM TO THE CUSTOMER OR FSE CAUSED BY THE LEAK HOWEVER THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. BLEACH WAS USED TO CLEAN AND DISINFECT THE INSTRUMENT AND SURROUNDING AREAS. THE CLOG IN THE WASTE PUMP HEAD WAS DUE TO CORES FROM THE YELLOW VACUTAINER CAPS. THE TUBES USED ARE BD VACUTAINER ACD SOLUTION A #364606. THE PROBE HAD 571 PIERCINGS AND WAS LOT# F164970. THE BLOCKAGE WAS CLEARED AFTER DISASSEMBLING THE HEAD AND FLUSHING WITH DI WATER. THE PUMP WAS REASSEMBLED, AND THE COUPLINGS WERE REPLACED TO AVOID ANY FURTHER CORES FROM GOING DOWNSTREAM PAST THE FILTER. THE FILTER WAS INSPECTED. THE INSTRUMENT WAS TESTED AND VERIFIED AS OPERATING TO SPECS. THE PROBLEM WAS CORRECTED AND THERE WAS NO FURTHER LEAKING OR BLOCKAGE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4). INSTALL DATE: (B)(6) 2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: LEAK AT STATION; O PROBLEM DESCRIPTION: CLOGGED; O CAUSE: PARTICLES FROM SAMPLE TUBE CAP; WORK PERFORMED: CLEARED FLUIDIC LINES AND CLEANED FITTINGS; SOLUTION: CLEARED FLUIDIC LINES AND CLEANED FITTINGS. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR 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 PARTICLES CLOGGING THE FLUIDIC LINES/CONNECTORS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED FOR THE LEAK.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MACHINE OVERFLOWS, PARTS ARE WORN. 1) WAS THE LEAK LIQUID OR AIR? LIQUID. 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? PER WO NOTES - NOT CONTAINED. 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO SPRAY; YES IT WAS UNDER PRESSURE. 4) WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. 8) WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? NA. 9) WHAT PERSONAL PROTECTIVE EQUIPMENT WAS BEING USED DURING THE OCCURRENCE? GLOVES, GLASSES, GOWN, MASK. 10) WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. 11) WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO. 12) WHAT IS THE CURRENT MEDICAL STATUS? NA.