BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2022-00707
- Event Type
- Malfunction
- Date Received
- August 4, 2022
- Date of Event
- July 1, 2022
- Report Date
- August 18, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679831
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1134641. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-05-14. MEDICAL DEVICE LOT #: 1151104. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-05-31. MEDICAL DEVICE LOT #: 1179691. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2021-06-28. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY MATERIAL #: 367956 LOT/BATCH #: 1134641, 1151104, 1179691 BD HAD NOT RECEIVED SAMPLES, BUT 9 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR SERUM AND GEL AIR BUBBLES WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR SERUM AND GEL AIR BUBBLES WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, GEL AIR BUBBLES, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 MODE POOR SERUM AND GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR SERUM AND GEL AIR BUBBLES 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. 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 PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND AIR BUBBLES IN THE GEL. THIS POOR BARRIER SEPARATION EVENT OCCURRED POOR BARRIER OF SAMPLE 75 TIMES. THIS AIR BUBBLES EVENT OCCURRED 75 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SST 3.5 ML TUBES REQUIRED TO BE ANALYSED TWICE DUE TO ERROR SHOWING IN 1ST ATTEMPT LIKE NO RESULTS, HIGH VISCOSITY, BUBBLE FORMATION."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND AIR BUBBLES IN THE GEL. THIS POOR BARRIER SEPARATION EVENT OCCURRED POOR BARRIER OF SAMPLE 75 TIMES. THIS AIR BUBBLES EVENT OCCURRED 75 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SST 3.5 ML TUBES REQUIRED TO BE ANALYSED TWICE DUE TO ERROR SHOWING IN 1ST ATTEMPT LIKE NO RESULTS, HIGH VISCOSITY, BUBBLE FORMATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2433491 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 367983 | SEE H.10 | 50382903679831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |