BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6) PROBLEM STATEMENT: CUSTOMER REPORTED: INJECTION NEEDLE LEAKING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13APR2020 TO DATE 13APR2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 10 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13APR2020 TO DATE 13APR2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED THE WASTE PUMP ASSEMBLY. INSTRUMENT IS OPERATING NORMALLY. THERE WAS NO CONTACT WITH THE FLUID. NO OTHER INFORMATION AVAILABLE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 01872747 INSTALL DATE: 12DEC2018 DEFECTIVE PART NUMBER: 334297 MINIWASH ASSEMBLY WORK ORDER NOTES: O SUBJECT / REPORTED: INJECTION NEEDLE LEAKING O PROBLEM DESCRIPTION: WASTE PUMP DEFECTIVE O CAUSE: WASTE PUMP DEFECTIVE O WORK PERFORMED: REPLACED MINIWASH ASSEMBLY O SOLUTION: REPLACED DEFECTIVE WASTE PUMP (MINIWASH ASSEMBLY) RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 02 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 ASSISTANT III IFU 23-13406-03 VER A - REV 01 O RISK CONTROL:_ALARP_____ O MITIGATION(S) SUFFICIENT ¿YES ¿NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS DEFECTIVE WASTE PUMP CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE INJECTION NEEDLE LEAKING. SEE H10.

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 IMPACT TO USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: SPA III-SAMPLE LEAKING FROM THE INJECTION NEEDLE 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 UNDER PRESSURE? (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): NO. 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 CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID?(IF NO, NO FURTHER QUESTIONS REQUIRED.): NO.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS INITIAL REPORTER PHONE #: (B)(6). 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 IMPACT TO USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SPA III-SAMPLE LEAKING FROM THE INJECTION NEEDLE 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 UNDER PRESSURE? (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):NO. 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 CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID?(IF NO, NO FURTHER QUESTIONS REQUIRED.):NO.