BD FACSLYRIC¿

Additional Manufacturer Narrative

H.6 BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE SIT DRIPPING WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR THE SIT DRIPPING WAS AN ADJUSTMENT FOR THE V8 VALVE TUBING THE CUSTOMER REPORTED A COMPLAINT REGARDING THE SIT DRIPPING. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A FIELD VISIT AND PERFORMED A REPAIR. THEY MOVED THE TUBING ON V8 VALVE. AFTER THE ADJUSTMENT THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS INTENDED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE ERRONEOUS PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CONTAMINATION OF A PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED BY CUSTOMER THAT SIT DRIPPING." ¿MDR SAFETY CHECKLIST : CONTAMINATION : 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES OR UNKNOWN, GO TO PATIENT SAMPLES CHECKLIST): YES. MDR SAFETY CHECKLIST : PATIENT SAMPLES 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CONTAMINATION OF A PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED BY CUSTOMER THAT SIT DRIPPING." ¿MDR SAFETY CHECKLIST : CONTAMINATION : 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES OR UNKNOWN, GO TO PATIENT SAMPLES CHECKLIST): YES. MDR SAFETY CHECKLIST : PATIENT SAMPLES 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

Additional Manufacturer Narrative

E.1 INITIAL REPORTER ADDRESS: (B)(6). G5. PMA / 510(K)#: BK230835, K170974, K201814. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.