BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received Nov 18, 2025 · Event occurred Oct 23, 2025
Report 1917413-2025-01567 · MDR key 23589610
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
5069090
Product problems
- Material Deformation
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BD RECEIVED 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE STOPPER MOLDING WAS OBSERVED. 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 DEFECTIVE STOPPER MOLDING. 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.
Description of Event or Problem
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE TUBE HAD A DEFECTIVE CAP MOLDING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER."