UNSPECIFIED BD VACUTAINER® CPT TUBE
Received Aug 18, 2025 · Event occurred Jul 29, 2025
Report 1917413-2025-01122 · MDR key 22829083
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Device Ingredient or Reagent Problem
- Improper Chemical Reaction
- Device Ingredient or Reagent Problem
- Improper Chemical Reaction
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
Description of Event or Problem
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER® CPT TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT HEMOLYSIS AND POOR BARRIER SEPARATION(INCOMPLETE RBC SEPARATION). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN 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 WHILE USING AN UNSPECIFIED BD VACUTAINER® CPT TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT HEMOLYSIS AND POOR BARRIER SEPARATION(INCOMPLETE RBC SEPARATION). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.