BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML

Additional Manufacturer Narrative

E1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (BROWN THREADS FLOATING IN THE LOWER FICOLL LIQUID). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (BROWN THREADS FLOATING IN THE LOWER FICOLL LIQUID). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS EVALUATED, AND FLOATING REDDISH-BROWN STRANDS ARE SEEN IN THE LIQUID DENSITY MEDIA(LDM) LAYER OF THE TUBE. PER THE SPECIFICATION, THESE ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE COMPOSED OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LDM. THEY 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.