BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2022-00505
- Event Type
- Malfunction
- Date Received
- August 17, 2022
- Date of Event
- July 27, 2022
- Report Date
- October 27, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903678612
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 #: 2109087. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2022-04-19. MEDICAL DEVICE LOT #: 2080662. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2022-03-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 8.12.2022. H.6. INVESTIGATION SUMMARY: BD RECEIVED 10 CUSTOMER SAMPLES FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE SAMPLES WERE TESTED AND NO ISSUES RELATING TO CLOTTING WERE OBSERVED. 100 RETENTION SAMPLES FROM BOTH LOTS WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOTTING) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH CUSTOMER AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. 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 CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE FACTORS THAT MAY CONTRIBUTE TO CLOTTING 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 THAT BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ARE EXPERIENCING CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS A COMMERCIAL REFERENCE LAB REPORTING CLOTTING ISSUES WITH 4.0 ML EDTA TUBES 367861 AT MULTIPLE DRAW STATIONS/LOCATIONS.CUSTOMER HAS HAD TO RECOLLECT PATIENTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: AFFECTED LOT#S 2109087 AND 2080662"
IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ARE EXPERIENCING CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS A COMMERCIAL REFERENCE LAB REPORTING CLOTTING ISSUES WITH 4.0 ML EDTA TUBES 367861 AT MULTIPLE DRAW STATIONS/LOCATIONS.CUSTOMER HAS HAD TO RECOLLECT PATIENTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: AFFECTED LOT#S 2109087 AND 2080662."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1915373 | BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367861 | SEE H.10 | 50382903678612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |