VACUTAINER CPT
Received Jul 10, 2025 · Event occurred Jun 13, 2025
Report 1917413-2025-00891 · MDR key 22470649
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362760
Lot number
4262287
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 CITRATE, 10 SAMPLES EXHIBITED EITHER POOR BARRIER SEPARATION AFTER PROCESSING OR LOW YIELD. CUSTOMER WAS UNABLE TO DETERMINE THE SPECIFIC OCCURRENCE FOR EACH ISSUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 01-JUL-2025 INVESTIGATION SUMMARY BD RECEIVED 42 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE INSPECTED WITH NO ISSUES OBSERVED. THE BD IFU (INSTRUCTIONS FOR USE) DOES NOT PROVIDE FOR ANY SPECIFIC YIELD CLAIMS, RATHER A PERCENT RECOVERY OF THE PATIENT'S WHOLE BLOOD CELL COUNT. YIELDS DEPEND ON THE PATIENT, THE QUALITY OF THE SPECIMEN, AND THE METHOD USED FOR ISOLATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JUNE 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION BASED ON THE PHOTOS PROVIDED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR LOW YIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR 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, 10 SAMPLES EXHIBITED EITHER POOR BARRIER SEPARATION AFTER PROCESSING OR LOW YIELD. CUSTOMER WAS UNABLE TO DETERMINE THE SPECIFIC OCCURRENCE FOR EACH ISSUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.