BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. FOR LOT NUMBER 5196738, A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND THE CLOSURE WAS CORRECTLY PLACED ON THE TUBES. ADDITIONALLY, FUNCTIONAL TESTS WERE PERFORMED ON 10 RETAINED SAMPLES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS, WITH NO ISSUES IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5196738, FOR THE INDICATED FAILURE MODE: DRAW VOLUME. 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 WHILE USING BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.