BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Jun 9, 2025 · Event occurred May 13, 2025
Report 1917413-2025-00749 · MDR key 22171429
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362761
Lot number
4262290
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. A VISUAL EXAMINATION OF THESE PHOTOS REVEALED POOR BARRIER SEPARATION. ADDITIONALLY, 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 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 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, POOR BARRIER SEPARATION WAS SEEN IN ONE FETAL SAMPLE. THE SAMPLE WAS CENTRIFUGED FURTHER FOR AN ADDITIONAL 10 MINUTES (PER INSTRUCTION FOR USE) WITH THE SAME OUTCOME (POOR BARRIER SEPARATION). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
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 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, POOR BARRIER SEPARATION WAS SEEN IN ONE FETAL SAMPLE. THE SAMPLE WAS CENTRIFUGED FURTHER FOR AN ADDITIONAL 10 MINUTES (PER INSTRUCTION FOR USE) WITH THE SAME OUTCOME (POOR BARRIER SEPARATION). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.