BD VIPER¿ SYSTEM

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD VIPER¿ SYSTEM. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "FOR THE PAST THREE DAYS, THE INSTRUMENT HAS BEEN CONTAMINATED WITH GC. THE CUSTOMER HAS TRIED TO EXTENSIVELY DECONTAMINATE THE INSTRUMENT BUT THIS IS STILL SHOWING UP, AND THEY ARE NOW REQUESTING SUPPORT ON THIS.

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY:THE COMPLAINT ALLEGES THE BD VIPER XTR INSTRUMENT (CATALOG NUMBER 441091 AND SERIAL NUMBER: (B)(6)) HAD "FALSE POSITIVES". CUSTOMER REPORTED THAT FOR THE PAST FEW DAYS THEIR INSTRUMENT HAS BEEN CONTAMINATED WITH GC. THE CUSTOMER HAS ATTEMPTED TO DECONTAMINATE THE INSTRUMENT BUT ARE UNABLE TO RESOLVE THE ISSUE. CUSTOMER REQUESTS FURTHER ASSISTANCE. APPLICATION SPECIALISTS INSTRUCTED THE CUSTOMER TO PERFORM 3 ROUNDS OF DEEP CLEANING, INCLUDING LAB TOUCH POINTS, AND TO PERFORM EM TESTING TO CONFIRM IF CLEANING IS SUCCESSFUL. AFTER MULTIPLE ROUNDS OF CLEANING, THE CUSTOMER CONFIRMED THAT THE CONTAMINATION ISSUE HAS BEEN RESOLVED. THIS COMPLAINT IS UNCONFIRMED AS THE COMPLAINT ALLUDES TO A CONTAMINATION ISSUE AND THE INSTRUMENT IS OPERATING TO BD SPECIFICATIONS. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE COMPLAINT IS UNCONFIRMED, THUS A DHR REVIEW WOULD YIELD NO USEFUL INFORMATION. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD VIPER¿ SYSTEM. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "FOR THE PAST THREE DAYS, THE INSTRUMENT HAS BEEN CONTAMINATED WITH GC. THE CUSTOMER HAS TRIED TO EXTENSIVELY DECONTAMINATE THE INSTRUMENT BUT THIS IS STILL SHOWING UP, AND THEY ARE NOW REQUESTING SUPPORT ON THIS. "