BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Apr 3, 2025 · Event occurred Feb 26, 2025
Report 1917413-2025-00387 · MDR key 21762796
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362760
Lot number
4142089
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
Description of Event or Problem
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. AFTER RE-SPINNING BOTH TUBES, BOTH STILL EXHIBITED POOR BARRIER SEPARATION(4 OCCURRENCES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED FIVE PHOTOS FOR INVESTIGATION. A VISUAL EXAMINATION OF THESE PHOTOS REVEALED POOR BARRIER SEPARATION. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2025; ADDITIONAL TESTING WAS PERFORMED: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (POOR SEPARATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED DEMONSTRATED DISTINCT LAYERS AS EXPECTED. 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 BASED ON THE PHOTOS PROVIDED. 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.
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 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. AFTER RE-SPINNING BOTH TUBES, BOTH STILL EXHIBITED POOR BARRIER SEPARATION(4 OCCURRENCES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.