MalfunctionJCF

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Received Oct 22, 2025 · Event occurred Sep 23, 2025

Report 1917413-2025-01454 · MDR key 23359175

Device

Generic name

Lymphocyte Separation Medium

Manufacturer

Becton, Dickinson & Co. (broken Bow)

Catalog number

362760

Lot number

5107736

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

Description of Event or Problem

REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 SAMPLE EXHIBITED POOR BARRIER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

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.