BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received Dec 4, 2025 · Event occurred Nov 7, 2025
Report 1917413-2025-01622 · MDR key 23722217
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
5020999
Product problems
- Break
- Break
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 THAT WHILE USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE TUBE WAS FOUND BROKEN DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE TUBE WAS FOUND BROKEN DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
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: 25-NOV-2025. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE ALONG WITH THREE PHOTOS FOR INVESTIGATION. UPON EVALUATION OF BOTH, IT WAS OBSERVED THAT THE GLASS TUBE IS BROKEN. 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: 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.