BD FACS¿ SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SPA III (337170 UPGRADED) LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER WASH STATION IS OVERFLOWING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. 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? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? WHAT PERSONAL PROTECTIVE EQUIPMENT WAS BEING USED DURING THE OCCURRENCE? WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? WHAT IS THE CURRENT MEDICAL STATUS?

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4) PN: (B)(4) SPAIII SN: T0425 DATE REPORTED: 06/20/2022 ¿ INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 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 (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS) O COMPLAINT DATA ATTACHED ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: O REPLACED WASTE PUMP O REPLACED INLINE FILTER O NO FURTHER ISSUES O SAMPLE PREPARATION WAS NOT AFFECTED. O THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4) INSTALL DATE: (B)(6) 2009 DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH PUMP, 640835 FILTER INLINE KIT WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING O PROBLEM DESCRIPTION: FLUID LEAK O CAUSE: DEFECTIVE WASTE PUMP ¿ CLOGGED IN-LINE FILTER O WORK PERFORMED: REPLACED WASTE PUMP AND IN-LINE FILTER O SOLUTION: REPLACED WASTE PUMP AND IN-LINE FILTER ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PARTS ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN650686 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO HAZARD ID: 3.1.29 _ HAZARD: ENVIRONMENTAL BIOHAZARD SEVERITY: 5 PROBABILITY: 1 RISK INDEX: 5 O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ O RISK CONTROL:_AFAP_____ O MITIGATION(S) SUFFICIENT YES NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE WASTE PUMP AND CLOGGED INLINE FILTER ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH STATION OVERFLOWING. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SPA III (337170 UPGRADED) LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER WASH STATION IS OVERFLOWING. 1) WAS THE LEAK LIQUID OR AIR? LIQUID 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO 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? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO 8) WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? 9) WHAT PERSONAL PROTECTIVE EQUIPMENT WAS BEING USED DURING THE OCCURRENCE? 10) WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? 11) WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? 12) WHAT IS THE CURRENT MEDICAL STATUS?