BD VACUTAINER® SST¿
Report
- Report Number
- 1024879-2025-01214
- Event Type
- Malfunction
- Date Received
- September 8, 2025
- Date of Event
- August 11, 2025
- Report Date
- February 4, 2026
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 30382903679837
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. E1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: REPORT 2 OF 2: IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ TUBES, A GEL-LIKE SUBSTANCE COATS THE ANALYZER'S PROBE LEADING TO INSUFFICIENT SAMPLING AND ABNORMAL K+, NA+, AND CL- RESULTS. NO ERRONEOUS RESULTS WERE REPORTED. THE SAMPLE WAS RE-TESTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED. H6: EVENT PROBLEM AND EVALUATION CODES: IMDRF ANNEX A GRID: ADDITIONAL A CODE WAS ADDED - A0908 - INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS.
INVESTIGATION SUMMARY, BD RECEIVED 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES WAS NOT OBSERVED. THE PHOTOS SHOW AN ANALYZER PROBE COVERED IN A GEL-LIKE SUBSTANCE, ALONG WITH LAB RESULTS INDICATING AN OUT-OF-RANGE RESULT FOR CL. THE PHOTOS PROVIDED DO NOT SHOW ANY BD TUBES SHOWING THE REPORTED DEFECT. ERRONEOUS RESULTS CANNOT BE ANALYZED THROUGH PHOTOS. THEREFORE, USING RETENTION SAMPLES; FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AS ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODES (OIL GEL GLOBULES AND ERRONEOUS RESULTS-POTASSIUM, SODIUM, CHLORIDE) BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 2025. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES OIL GEL GLOBULES AND ERRONEOUS RESULTS (POTASSIUM, SODIUM, CHLORIDE). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT OIL GEL GLOBULES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
REPORT 2 OF 2: IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ TUBES, A GEL-LIKE SUBSTANCE COATS THE ANALYZER'S PROBE LEADING TO INSUFFICIENT SAMPLING AND ABNORMAL K+, NA+, AND CL- RESULTS. NO ERRONEOUS RESULTS WERE REPORTED. THE SAMPLES WERE RE-TESTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
REPORT 2 OF 2: IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ TUBES, A GEL-LIKE SUBSTANCE COATS THE ANALYZER'S PROBE LEADING TO INSUFFICIENT SAMPLING AND ABNORMAL K+, NA+, AND CL- RESULTS. NO ERRONEOUS RESULTS WERE REPORTED. THE SAMPLES WERE RE-TESTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2056505 | BD VACUTAINER® SST¿ | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON, DICKINSON & CO., (BD) | 4339094 | 30382903679837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |