BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Dec 19, 2024 · Event occurred Dec 6, 2024
Report 1917413-2024-01254 · MDR key 20978798
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362761
Lot number
4078002
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
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 4078002 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025 H4. DEVICE MANUFACTURE DATE: 18-MAR-2024 D.4 UDI#: (B)(6). INVESTIGATION SUMMARY BD RECEIVED, 2 PHOTOS, AND 1 VIDEO FOR INVESTIGATION. VISUAL EXAMINATION OF THE PHOTOS AND VIDEO WAS PERFORMED AND REVEALED THE CUSTOMER¿S INDICATED FAILURE MODE. 60 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. OIL DROPLETS ARE SMALL SPHERICAL DROPS OF FLUID RESEMBLING A FAT DROPLET AND MAY SOMETIMES BE SEEN FLOATING IN THE SERUM OR ON THE SURFACE OF THE SERUM COLLECTED IN GEL SEPARATOR TUBES. GEL GLOBULES ARE SIMILAR IN NATURE TO OIL DROPLETS BUT POSSESS THE PROPERTIES OF THE GEL MATERIAL AND COMPRISE SMALL PIECES OF GEL THAT HAVE BROKEN AWAY FROM THE GEL BARRIER. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2024. 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 THE INDICATED FAILURE MODE OIL GEL GLOBULES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES IN THE PLASMA AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED OIL GEL GLOBULES IN THE PLASMA AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.