BD FACS¿ SAMPLE PREP ASSISTANT III

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 DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS LEAKING INSIDE OF THE Y TOWER. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NO. 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.

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: LEAKING INSIDE THE TOWER. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14MAR2021 TO DATE 14MAR2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 15 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14MAR2021 TO DATE 14MAR2022 (ROLLING 12 MONTHS). ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE CUSTOMER REPORTED AN UNKNOWN LEAK AT THE TOWER. TIGHTEN DI WATER FITTING. TESTED INSTRUMENT WITH NO ISSUES. INSTRUMENT WAS RETURNED TO CUSTOMER IN FULLY WORKING CONDITION FOR REGULAR USE. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02373029. INSTALL DATE: 29SEP2015. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: LEAKING INSIDE THE TOWER. O PROBLEM DESCRIPTION: UNKNOWN FLUID LEAK. O CAUSE: LOOSE DI WATER CONNECTION. O WORK PERFORMED: TIGHTENED DI WATER CONNECTION. O SOLUTION: TIGHTENED DI WATER CONNECTION. ¿ 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: 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 LOOSE DI WATER CONNECTOR. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE TOWER FLUID LEAK. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS LEAKING INSIDE OF THEY TOWER. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NO. 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.

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: LEAKING INSIDE THE TOWER ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14MAR2021 TO DATE 14MAR2022 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE 15 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14MAR2021 TO DATE 14MAR2022 (ROLLING 12 MONTHS) ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE CUSTOMER REPORTED AN UNKNOWN LEAK AT THE TOWER. TIGHTEN DI WATER FITTING. TESTED INSTRUMENT WITH NO ISSUES. INSTRUMENT WAS RETURNED TO CUSTOMER IN FULLY WORKING CONDITION FOR REGULAR USE. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: 29SEP2015. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: LEAKING INSIDE THE TOWER. O PROBLEM DESCRIPTION: UNKNOWN FLUID LEAK. O CAUSE: LOOSE DI WATER CONNECTION. O WORK PERFORMED: TIGHTENED DI WATER CONNECTION. O SOLUTION: TIGHTENED DI WATER CONNECTION. ¿ RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN647205 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 LOOSE DI WATER CONNECTOR. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE TOWER FLUID LEAK. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS LEAKING INSIDE OF THE Y TOWER. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? N. 3. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? N. 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.