BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: BD RECEIVED SIX PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS REVEALED FLOATING REDDISH-BROWN STRANDS IN THE LIQUID DENSITY MEDIA (LDM) LAYER OF THE TUBE. THESE STRANDS ARE COMPOSED OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LDM, WHICH ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE NOT CONSIDERED FOREIGN MATTER AS THEY ARE INTRINSIC TO THE COMPONENTS OF THE TUBE. 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 - UNKNOWN. 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 USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE 110 TUBES CONTAINED FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.