BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Apr 2, 2025 · Event occurred Mar 4, 2025
Report 1917413-2025-00370 · MDR key 21753739
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362761
Lot number
3354398
Product problems
- Coagulation in Device or Device Ingredient
- Coagulation in Device or Device Ingredient
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION, WHICH WERE EVALUATED AND DID NOT SHOW THE CUSTOMER'S INDICATED FAILURE MODE OF POOR PLASMA. ADDITIONALLY, 28 RETAINED SAMPLES WERE INSPECTED, AND NO ISSUES WERE IDENTIFIED. THE PRODUCT'S EXPIRY DATE IS 31 DEC 2024. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2025, ADDITIONAL TESTING MAY BE REQUIRED: FURTHER CLINICAL TESTING COULD NOT BE CONDUCTED AS THE TUBES EXPIRED 31DEC2024. CLINICAL EVALUATION CANNOT BE CONDUCTED ON EXPIRED TUBES. FURTHERMORE CLINICAL TESTING IS NOT INDICATED AS THE CUSTOMER RESOLVED THE ISSUE BY PERFORMING THE WASH STEPS RECOMMENDED IN THE INSTRUCTIONS FOR USE(IFU) WITH PHOSPHATE BUFFERED SALINE (PBS) SOLUTION. NO FURTHER TESTING IS REQUIRED. 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE,1 SAMPLE EXHIBITED CLUMPING DURING THE CELL WASHING/RESUSPENSION PHASE POST-CENTRIFUGATION. CELLS ARE NOT CLUMPED INITIALLY UPON HARVESTING; CLUMPING APPEARS DURING THE 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,1 SAMPLE EXHIBITED CLUMPING DURING THE CELL WASHING/RESUSPENSION PHASE POST-CENTRIFUGATION. CELLS ARE NOT CLUMPED INITIALLY UPON HARVESTING; CLUMPING APPEARS DURING THE WASH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.