BD FACS¿ SAMPLE PREP ASSISTANT III

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 THERE WAS LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT UNIT IS LEAKING. 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? NO. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) UNKNOWN. 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. AS PER TECH SERVICE REP: "THIS IS WHAT THE CUSTOMER SAID TO ME. THERE WAS COLORING IN THE FLUID AND NOT MUCH FLUID GOING INTO THE WASTE TANK. THE COMMENT FROM THE FIELD SERVICE ENGINEER WAS THERE WAS A CRACKED FITTING.¿ THE FSE DID A PHONE CONSULTATION, WAS NOT ON SITE. AS PER THE FSE "THIS IS WHAT IS ON MY WO. ¿UNIT IS LEAKING. CUSTOMER TO DETERMINE WHERE LEAK IS COMING FROM. WHEN I CALLED THE ONSITE PERSON SAID IT WAS AFTER THEY INITIALIZED. THERE IS NO SAMPLE INVOLVED IN INITIALIZATION." WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? NON-BIOHAZARD. WHEN I CALLED THE ONSITE PERSON SAID IT WAS AFTER THEY INITIALIZED. THERE IS NO SAMPLE INVOLVED IN INITIALIZATION."

Additional Manufacturer Narrative

H. 6 INVESTIGATION SUMMARY (B)(4) PN: 647205. SPAIII. SN: (B)(6). DATE REPORTED: 06/13/2022. INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: SPA UNIT IS LEAKING. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13JUN2021 TO DATE 13JUN2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 11 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13JUN2021 TO DATE 13JUN2022 (ROLLING 12 MONTHS). O COMPLAINT DATA ATTACHED. ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: INSTRUCTED CUSTOMER HOW TO BACKFLUSH FITTING FROM SCREEN INLET TO REMOVE CLOG. PROCEDURE WAS SUCCESSFUL AND OPERATION RETURNED TO NORMAL. UNIT NOW FUNCTIONAL WITHOUT LEAKS. 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# 02492308. INSTALL DATE: 09NOV2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: SPA UNIT IS LEAKING. O PROBLEM DESCRIPTION: FLUID LEAK. O CAUSE: CLOGGED FITTING AT INLET SCREEN. O WORK PERFORMED: CUSTOMER CLEARED/BACKFLUSHED INLET FITTING. O SOLUTION: CUSTOMER CLEARED/BACKFLUSHED INLET FITTING. ¿ 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 OR NO? O HAZARD ID: (B)(6). 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 OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A CLOGGED INLET FITTING. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR SPA UNIT LEAKING. 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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAIMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. IT WAS REPORTED BY THE CUSTOMER THAT UNIT IS LEAKING. 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? NO. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE): UNKNOWN. 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. AS PER TECH SERVICE REP: "THIS IS WHAT THE CUSTOMER SAID TO ME. THERE WAS COLORING IN THE FLUID AND NOT MUCH FLUID GOING INTO THE WASTE TANK. THE COMMENT FROM THE FIELD SERVICE ENGINEER WAS THERE WAS A CRACKED FITTING.¿ THE FSE DID A PHONE CONSULTATION, WAS NOT ON SITE. AS PER THE FSE "THIS IS WHAT IS ON MY WO. ¿UNIT IS LEAKING. CUSTOMER TO DETERMINE WHERE LEAK IS COMING FROM. WHEN I CALLED THE ONSITE PERSON SAID IT WAS AFTER THEY INITIALIZED. THERE IS NO SAMPLE INVOLVED IN INITIALIZATION." WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? NON-BIOHAZARD. WHEN I CALLED THE ONSITE PERSON SAID IT WAS AFTER THEY INITIALIZED. THERE IS NO SAMPLE INVOLVED IN INITIALIZATION."