BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Mar 25, 2025 · Event occurred Feb 25, 2025
Report 1917413-2025-00314 · MDR key 21690056
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362760
Lot number
4078996
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES HAD AN INSUFFICIENT CELLULAR PELLET AFTER THE 2ND WASH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES HAD AN INSUFFICIENT CELLULAR PELLET AFTER THE 2ND WASH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 55 RETAINED SAMPLES WERE VISUALLY INSPECTED, WITH NO ISSUES BEING IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY 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 BARRIER SEPARATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED; HOWEVER, THE COMPLAINT ENTRY INDICATES PROCESSING STEPS MAY HAVE NOT BEEN FOLLOWED. 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.