BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E1: INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES AND POOR BARRIER SEPARATION WAS OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OIL GEL GLOBULES AND POOR BARRIER SEPARATION BASED ON THE PHOTO PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

Description of Event or Problem

IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 7 TUBES HAD OIL GEL GLOBULES AND POOR BARRIER SEPARATION AFTER CENTRIFUGATION OF THE SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.