inforMED
MalfunctionJCF

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Received Jul 7, 2026 · Event occurred Jun 12, 2026

Report 1917413-2026-00595 · MDR key 25742277

Device

Generic name

Lymphocyte Separation Medium

Catalog number

362761

Lot number

UNKNOWN

Product problems

  • Break

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, TWO (2) TUBES BROKE INSIDE OF THE CENTRIFUGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWNH.4. DEVICE MANUFACTURE DATE: UNKNOWNINVESTIGATION SUMMARY:BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.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.