MalfunctionJCF

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Received Jun 19, 2026 · Event occurred May 21, 2026

Report 1917413-2026-00554 · MDR key 25561922

Device

Generic name

Lymphocyte Separation Medium

Manufacturer

Becton Dickinson & Co (franklin Lakes)

Catalog number

362761

Lot number

5287685

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE BROKE DURING PROCESSING IN THE CENTRIFUGE AND LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.