BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III WASTE TOWER IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) NON-WASTE 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

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 WASTE TOWER IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) NON-WASTE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.

Additional Manufacturer Narrative

UPDATED G TAB- DATE RECEIVED FROM MANUFACTURER FROM 08/03/2017 TO 08/03/2022. H. 6 INVESTIGATION SUMMARY (B)(4). PN: 647205. SPAIII SN: (B)(6). DATE REPORTED: 08/03/2022. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASTE 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 03AUG2021 TO DATE 03AUG2022 (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: REPLACED THE MINIWASH ASSEMBLY AND 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) 2018. DEFECTIVE PART NUMBER: 640835-INLINE FILTER KIT, 33429709-MINIWASH ASSEMBLY, 339112-CLAMP. TUBE WORK ORDER NOTES: SUBJECT / REPORTED: WASTE TOWER IS OVERFLOWING. PROBLEM DESCRIPTION: WASH TOWER IS OVERFLOWING. CAUSE: CLOGGED WASH TOWER FLUIDIC LINE AND FILTER WORK PERFORMED: REPLACED MINIWASH ASSEMBLY AND INLINE FILTER. SOLUTION: REPLACED MINIWASH ASSEMBLY AND INLINE 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 (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 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: AFAP MITIGATION(S) SUFFICIENT YES. NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASH TOWER FLUIDIC LINE AND INLINE FILTER CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER 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. CORRECTION: INCORRECT DATE RECEIVED BY MANUFACTURER ON MDR MFR REPORT ON G.7. THE CORRECT DATE SHOULD BE 08/03/2022 AND NOT 08/03/2017.

Additional Manufacturer Narrative

UPDATED G TAB- DATE RECEIVED FROM MANUFACTURER FROM: 08/03/2017 TO 08/03/2022. REMOVED "COMPLAINT DATA ATTACHED". H. 6 INVESTIGATION SUMMARY (B)(4) PN: (B)(6) SPAIII SN: (B)(6) DATE REPORTED: 08/03/2022 INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: WASTE 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) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE (B)(6) 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). ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: REPLACED THE MINIWASH ASSEMBLY AND 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)(4) 2018. DEFECTIVE PART NUMBER: 640835-INLINE FILTER KIT, 33429709-MINIWASH ASSEMBLY, 339112-CLAMP TUBE WORK ORDER NOTES: O SUBJECT / REPORTED: WASTE TOWER IS OVERFLOWING. O PROBLEM DESCRIPTION: WASH TOWER IS OVERFLOWING. O CAUSE: CLOGGED WASH TOWER FLUIDIC LINE AND FILTER. O WORK PERFORMED: REPLACED MINIWASH ASSEMBLY AND INLINE FILTER. O SOLUTION: REPLACED MINIWASH ASSEMBLY AND INLINE 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 PN (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART # (B)(4), REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES - NO. O HAZARD ID: 3.1.29. O HAZARD: ENVIRONMENTAL BIOHAZARD. O SEVERITY: 5. O PROBABILITY: 1. O 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 CLOGGED WASH TOWER FLUIDIC LINE AND INLINE FILTER. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER 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. CORRECTION: INCORRECT DATE RECEIVED BY MANUFACTURER ON MDR MFR REPORT #: 2916837-2022-00207 ON G.7. THE CORRECT DATE SHOULD BE 08/03/2022 AND NOT 08/03/2017. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III WASTE TOWER IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THERE A FLUIDIC LEAK OR SPILL?: YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE?: NO. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT?: NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION?: YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED?: SHEATH. 5. WHAT IS THE SOURCE OF LEAK/SPILL?: (WASTE OR NON-WASTE LINE) NON-WASTE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS?: NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK: NO.

Additional Manufacturer Narrative

CORRECTION: UPDATED DATE RECEIVED BY MANUFACTURER FROM 8/03/2022 TO 09/28/2022. THE DATE RECEIVED BY MANUFACTURER IN MDR 2916837-2022-00207 WAS INCORRECT.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III WASTE TOWER IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) NON-WASTE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.