BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE AND 9 PHOTOS FOR INVESTIGATION. THE RETURNED SAMPLE AND PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER (FM) WITH THE INCIDENT LOT WAS NOT OBSERVED. THE SAMPLE AND PHOTOS WERE EVALUATED AND FLOATING REDDISH-BROWN STRANDS ARE IN THE LIQUID DENSITY MEDIA LAYER OF THE TUBE. PER SPECIFICATION, THESE ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE COMPOSED OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LIQUID DENSITY MEDIA. THEY 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE FM. 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.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 1 TUBE CONTAINED FOREIGN MATTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.