BD VACUTAINER® SST¿ II ADVANCE
Report
- Report Number
- 9617032-2025-02049
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Date of Event
- October 27, 2025
- Report Date
- February 19, 2026
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 30382903679554
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: 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.
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE MODE (ERRONEOUS RESULTS) BECAUSE THE LOT NUMBER IS UNKNOWN. THE AFFECTED BATCH/LOT MUST BE SPECIFIED IN ORDER TO PERFORM CLINICAL TESTING. THE PUBLICATION DOES NOT ALLEGE A BD PRODUCT DEFICIENCY. THE AUTHORS CONDUCTED A COMPARATIVE EVALUATION OF POTASSIUM (K), CALCIUM (CA), AND PHOSPHORUS (P) STABILITY IN THREE BLOOD COLLECTION TUBE TYPES, BD VACUTAINER® SST¿ II SERUM SEPARATOR TUBES, LITHIUM HEPARIN TUBES WITHOUT GEL (LIH), AND BD VACUTAINER® BARRICOR¿ TUBES, IN PATIENTS WITH ESSENTIAL THROMBOCYTOSIS. SST II TUBES DEMONSTRATED CLINICALLY SIGNIFICANT ALTERATIONS IN K, CA, AND P WHEN COMPARED WITH LIH, AND THE COMPARISON OF BD BARRICOR¿ TO LIH REVEALED SIGNIFICANT DIFFERENCES IN K AND CA CONCENTRATIONS. THE RESULTS DO NOT INDICATE A BD PRODUCT ISSUE. THE AUTHORS REPORTED LOWER POTASSIUM VALUES IN BD VACUTAINER® SST¿ II TUBES; HOWEVER, THIS FINDING MUST BE INTERPRETED WITHIN THE CLINICAL CONTEXT OF ESSENTIAL THROMBOCYTOSIS. ELEVATED PLATELET COUNTS IN ET PATIENTS ARE KNOWN TO CAUSE PSEUDOHYPERKALEMIA DUE TO POTASSIUM RELEASE DURING CLOT FORMATION. VARIABILITY IN POTASSIUM IS ALSO COMMONLY INFLUENCED BY NUMEROUS HUMAN AND PREANALYTICAL FACTORS, AND THE PUBLICATION DOES NOT PROVIDE DETAILED INFORMATION REGARDING COLLECTION TECHNIQUE, CLOTTING DURATION, MIXING, TRANSPORT, OR OTHER PREANALYTICAL VARIABLES THAT WOULD BE REQUIRED TO ATTRIBUTE DIFFERENCES TO THE TUBE ITSELF. IN SUMMARY, THE DATA PRESENTED DO NOT SUGGEST ANY ISSUE WITH BD BLOOD COLLECTION PRODUCTS. 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.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE DURING A LITERATURE STUDY, THERE WAS A LARGER THAN EXPECTED DEVIANCE FOR POTASSIUM MEASUREMENTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE DURING A LITERATURE STUDY, THERE WAS A LARGER THAN EXPECTED DEVIANCE FOR POTASSIUM MEASUREMENTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2629309 | BD VACUTAINER® SST¿ II ADVANCE | EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR | JKA | BECTON, DICKINSON AND COMPANY (BD) | UNKNOWN | 30382903679554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |