inforMED
MalfunctionJCF

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Received May 8, 2026 · Event occurred Apr 9, 2026

Report 1917413-2026-00406 · MDR key 25124852

Device

Generic name

Lymphocyte Separation Medium

Catalog number

362761

Lot number

5230375

Product problems

  • Break
  • Material Deformation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

REPORT 3 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES CRACKED DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.