BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Sep 22, 2025 · Event occurred Aug 25, 2025
Report 1917413-2025-01326 · MDR key 23117666
Device
Generic name
Blood Specimen Collection Device
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362760
Lot number
4262287
Product problems
- Coagulation in Device or Device Ingredient
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Ingredient or Reagent Problem
- Coagulation in Device or Device Ingredient
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Ingredient or Reagent Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.6 IMDRF ANNEX A GRID : A0302 - DEVICE INGREDIENT OR REAGENT PROBLEM (2910) EVENT TYPE WAS UPDATED TO: 1) POOR BARRIER SEPARATION. OF SAMPLE. 2)AIR BUBBLES IN GEL. INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS INDICATED THE PRESENCE OF POOR BARRIER SEPARATION AND GEL AIR BUBBLES. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION AND GEL AIRBUBBLES - DURING USE. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
Description of Event or Problem
IT WAS REPORTED THAT WHEN USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, BLOOD DID NOT PASS THROUGH THE GEL ON THREE (3) SAMPLES, AND AN ADDITIONAL THREE (3) SAMPLES EXHIBITED AIR BUBBLES IN THE GEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
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 THAT WHEN USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, BLOOD DID NOT PASS THROUGH THE GEL ON THREE (3) SAMPLES, AND AN ADDITIONAL THREE (3) SAMPLES EXHIBITED AIR BUBBLES IN THE GEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.