BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML
Received Jun 3, 2025 · Event occurred May 6, 2025
Report 1917413-2025-00706 · MDR key 22135582
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362782
Lot number
4346581
Product problems
- Leak/Splash
- Leak/Splash
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® NC: 1.0ML FICOLL¿: 2.0ML, 2 TUBES BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY BD RECEIVED 1 PHOTO FOR INVESTIGATION, WHICH SHOWS THE SHELF LABEL ON THE CARTON; HOWEVER, IT DOES NOT SHOW THE CUSTOMER'S INDICATED FAILURE MODE: GLASS BREAKAGE. ADDITIONALLY, 60 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE. 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML, 2 TUBES BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.