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

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. A REVIEW OF THE PHOTO SHOWED THE PRESENCE OF POOR BARRIER SEPARATION WITH RED BLOOD CELL CONTAMINATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON THE PHOTO PROVIDED. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

Description of Event or Problem

REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT POOR BARRIER SEPARATION WHERE THE GEL LAYER IS COMING OFF AND PIECES ARE FLOATING IN THE PLASMA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. RETURNED TO MANUFACTURER: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9. DEVICE AVAILABLE FOR EVAL?: 03-FEB-2026. INVESTIGATION SUMMARY: BD RECEIVED 5 CUSTOMER SAMPLES (ONE SAMPLE WAS CONTAMINATED) AND ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE CONTAMINATED SAMPLE AND PHOTO CONFIRMED THE PRESENCE OF POOR BARRIER SEPARATION. THE VISUAL INSPECTION OF THE REMAINING CUSTOMER SAMPLES DID NOT SHOW ANY TUBE DEFECTS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON THE PHOTO PROVIDED. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

Description of Event or Problem

REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT POOR BARRIER SEPARATION WHERE THE GEL LAYER IS COMING OFF AND PIECES ARE FLOATING IN THE PLASMA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

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¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT POOR BARRIER SEPARATION WHERE THE GEL LAYER IS COMING OFF AND PIECES ARE FLOATING IN THE PLASMA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.