BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received Nov 11, 2025 · Event occurred Oct 23, 2025
Report 2243072-2025-01391 · MDR key 23527361
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
5069090
Product problems
- Material Protrusion/Extrusion
- Material Protrusion/Extrusion
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 WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THERE WAS A DEFECTIVE CAP MOLDING OBSERVED. AFTER USE, ONE CPT BLOOD COLLECTION TUBE (LOT: 5069090) CUSTOMER FOUND TO HAVE A LARGE, CHIPPED RUBBER STOPPER. IT IS ASSUMED THAT THE CHIP WAS THERE FROM THE BEGINNING.
Additional Manufacturer Narrative
THE MDR SUBMITTED WITH MFR REPORT #: 2243072-2025-01391 WAS SUBMITTED WITH THE INCORRECT SITE REGISTRATION NUMBER. THIS MDR IS NOW VOID AND AN MDR WITH THE CORRECT SITE REGISTRATION NUMBER WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THERE WAS A DEFECTIVE CAP MOLDING OBSERVED. AFTER USE, ONE CPT BLOOD COLLECTION TUBE (LOT: (B)(4)) CUSTOMER FOUND TO HAVE A LARGE, CHIPPED RUBBER STOPPER. IT IS ASSUMED THAT THE CHIP WAS THERE FROM THE BEGINNING.