BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Jun 16, 2025 · Event occurred May 20, 2025
Report 1917413-2025-00789 · MDR key 22215127
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4262298
Product problems
- Clumping in Device or Device Ingredient
- Clumping in Device or Device Ingredient
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 4 OF 4: IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES ARE NOT SEPARATED ADEQUATELY AFTER PROCESSING WITH ONE CENTRIFUGE SPIN. UNUSUAL TEXTURE OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S) ARE OBSERVED POSSIBLY INDICATING CLUMPING OR AGGREGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
REPORT 4 OF 4: IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES ARE NOT SEPARATED ADEQUATELY AFTER PROCESSING WITH ONE CENTRIFUGE SPIN. UNUSUAL TEXTURE OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S) ARE OBSERVED POSSIBLY INDICATING CLUMPING OR AGGREGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A TOTAL OF 60 RETAINED SAMPLES WERE VISUALLY INSPECTED, WITH NO ISSUES 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR PLASMA. 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.