BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Jun 11, 2025 · Event occurred May 16, 2025
Report 1917413-2025-00764 · MDR key 22189073
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4262298
Product problems
- Device Ingredient or Reagent Problem
- Device Ingredient or Reagent Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS FOR INVESTIGATION. VISUAL EVALUATION OF THESE PHOTOS SHOWED THE PRESENCE OF POOR BARRIER SEPARATION. A TOTAL OF 60 RETAINED SAMPLES WERE VISUALLY INSPECTED, WITH NO ISSUES BEING IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 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. 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 1 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 1 PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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
REPORT 1 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 1 PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.