BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received May 28, 2025 · Event occurred Apr 9, 2025
Report 1917413-2025-00686 · MDR key 22101671
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Ingredient or Reagent Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Ingredient or Reagent Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 14 SAMPLES EXHIBITED POOR BARRIER SEPARATION AND AN UNSPECIFIED NUMBER EXHIBITED POOR PLASMA. POOR BARRIER ISSUES INCLUDE: RBC CONTAMINATION IN GEL AND PBMC LAYER AND SLANTED GEL. CUSTOMER WILL RE-SPIN SOME SAMPLES WHICH LEADS TO A DECREASE IN CELL COUNTS(POOR PLASMA). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY- BD RECEIVED SIX PHOTOS FOR INVESTIGATION. THE EVALUATION OF THE PHOTOS CONFIRMED THE CUSTOMER¿S FAILURE MODES. THE RETENTIONS COULD NOT BE INSPECTED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: POOR BARRIER SEPARATION AND POOR PLASMA. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECTS. 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.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 14 SAMPLES EXHIBITED POOR BARRIER SEPARATION AND AN UNSPECIFIED NUMBER EXHIBITED POOR PLASMA. POOR BARRIER ISSUES INCLUDE: RBC CONTAMINATION IN GEL AND PBMC LAYER AND SLANTED GEL. CUSTOMER WILL RE-SPIN SOME SAMPLES WHICH LEADS TO A DECREASE IN CELL COUNTS (POOR PLASMA). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.