BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT FOREIGN MATTER/CONTAMINATION WAS OBSERVED DURING USE WITH BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THERE OCCURS SPILL OVER BETWEEN SAMPLES WHEN ANALYZING A RACK OF TUBES. SIT FLUSHES HAVE BEEN DONE. THERE IS NO BLOCKAGE, BECAUSE SUFFICIENT LIQUID IS TAKEN UP WHEN DOING A CLEANING.

Additional Manufacturer Narrative

BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE INSUFFICIENT FLUID DURING SIT FLUSH. FSE PERFORMED SYSTEM CHECKS AND THEN REPLACED FACSFLOW FILTER AND SAMPLE LINE. AFTERWARDS, THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. 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 FOREIGN MATTER/CONTAMINATION WAS OBSERVED DURING USE WITH BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THERE OCCURS SPILL OVER BETWEEN SAMPLES WHEN ANALYZING A RACK OF TUBES. SIT FLUSHES HAVE BEEN DONE. THERE IS NO BLOCKAGE, BECAUSE SUFFICIENT LIQUID IS TAKEN UP WHEN DOING A CLEANING.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.