BD FACSLYRIC¿

Additional Manufacturer Narrative

E.1- INITIAL REPORTER E-MAIL: (B)(6). E.2- INITIAL REPORTER ADDR 1: (B)(6). G.1- PMA / 510(K)#: K170974; K201814. H.3. 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 USAGE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE CAUSE OF THE COMPLAINT WAS CONFIRMED TO BE DUE TO DIRTY SIT FLUSH TUBING. THE CUSTOMER HAD REPORTED THAT THE INSTRUMENT WAS EXHIBITING CARRYOVER BETWEEN SAMPLES, AND A FIELD SERVICE ENGINEER (FSE) WAS SENT ONSITE TO INVESTIGATE THE ISSUE. THE FSE CONFIRMED THE ISSUE AND PROCEEDED TO CLEAN THE SIT FLUSH TUBING, RESEAT THE PINCH VALVE, AND CHANGED THE ASSAY SIT FLUSHES FROM 1 TO 3. THE INSTRUMENT WAS THEN FUNCTIONING AS EXPECTED AND WAS RETURNED TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT DIAGNOSIS OR TREATMENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USAGE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER.