BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Aug 15, 2025 · Event occurred Jul 23, 2025
Report 1917413-2025-01110 · MDR key 22815605
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
UNKNOWN
Product problems
- Device Ingredient or Reagent Problem
- Device Ingredient or Reagent Problem
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¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT GEL AIR BUBBLES(PIERCED GEL) AND THE BLOOD AND FICOLL SOLUTION MIX. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE VISUAL EVALUATION OF THE PHOTO CONFIRMED THE CUSTOMER¿S FAILURE MODE, GEL AIR BUBBLES. THE RETENTIONS COULD NOT BE INSPECTED AS THE LOT NUMBER IS UNKNOWN. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GEL AIR BUBBLES. 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¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT GEL AIR BUBBLES (PIERCED GEL) AND THE BLOOD AND FICOLL SOLUTION MIX. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.