BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Apr 30, 2025 · Event occurred Apr 2, 2025
Report 1917413-2025-00546 · MDR key 21936959
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362761
Lot number
4262290
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 EXHIBITED POOR BARRIER SEPARATION AND THE GEL CONSISTENCY WAS NOT ALWAYS FIRM (COULD BE GOOEY OR STRINGY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 07-APR-2025. INVESTIGATION SUMMARY: BD RECEIVED SIX SAMPLES AND FIVE PHOTOS FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. VISUAL EVALUATION OF THE RETURNED PHOTOS SHOWED THE PRESENCE OF POOR BARRIER SEPARATION. THE PHOTOS SHOW THE GEL IS ON THE SIDEWALL OF THE TUBE AFTER THE TUBE WAS CENTRIFUGED BUT DOES NOT SHOW INCORRECT GEL CONSISTENCY. ADDITIONALLY, 60 RETAINED SAMPLES WERE ALSO VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ADDITIVE ABNORMALITY(GEL CONSISTENCY ISSUE). 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION AND THE GEL CONSISTENCY WAS NOT ALWAYS FIRM (COULD BE GOOEY OR STRINGY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.