BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED FOUR PHOTOS FOR INVESTIGATION, WHICH SHOW FLOATING REDDISH-BROWN STRANDS IN THE LIQUID DENSITY MEDIA LAYER OF THE TUBE. THESE STRANDS, CONSISTING OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LIQUID DENSITY MEDIA, ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE NOT CONSIDERED FOREIGN MATTER AS THEY ARE INTRINSIC TO THE COMPONENTS OF THE TUBE. ADDITIONALLY, 60 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FOREIGN MATTER. 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 THE IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED A STRING-LIKE MATTER IN THE LIQUID DENSITY MEDIA (LDM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.