BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS 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 WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: A TUBE HAS BROKEN AND LIQUID COMES OUT. WAS THE LEAK FLUID OR AIR?LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: A TUBE HAS BROKEN AND LIQUID COMES OUT. 1. WAS THE LEAK FLUID OR AIR?: (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.) LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT?: ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE?: (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4) NO. 4. WHAT WAS THE FLUID THAT LEAKED?: (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5) BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE?: (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6)AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH?: (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAIMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. "7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID?: (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.) NO.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY PN: (B)(6), SPAIII, SN: (B)(6), DATE REPORTED: 07/18/2022, INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: BROKEN TUBE ¿ FLUID LEAK. ¿ MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 18JUL2021 TO DATE 18JUL2022 (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 18JUL2021 TO DATE 18JUL2022 (ROLLING 12 MONTHS). ¿ COMPLAINT DATA ATTACHED. ¿ INVESTIGATION RESULT / ANALYSIS: PER CALL AND FSE¿S COMMENTS: IDENTIFIED DAMAGED PART. SHIPPED 337628. CUSTOMER CONFIRMS THAT THE REPLACEMENT PART HAS BEEN RECEIVED AND THE PROBLEM HAS BEEN RESOLVED. THE SPA IS PERFORMING AS REQUIRED. ¿ NO FURTHER ISSUES. ¿ 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: 30JAN2014. DEFECTIVE PART NUMBER: 337628 ¿ SENSOR, FLUID, WASTE TANK WORK ORDER NOTES: ¿ SUBJECT / REPORTED: BROKEN TUBE. ¿ PROBLEM DESCRIPTION: FLUID LEAK. ¿ CAUSE: BROKEN TUBE ASSEMBLY. ¿ WORK PERFORMED: REPLACE BROKEN TUBE ASSEMBLY. ¿ SOLUTION: REPLACED BROKEN TUBE ASSEMBLY. ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF BROKEN PART. ¿ 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: ¿ 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 A BROKEN TUBE ASSEMBLY. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR BROKEN TUBE. 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.