BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2024-00317
- Event Type
- Malfunction
- Date Received
- March 8, 2024
- Date of Event
- February 14, 2024
- Report Date
- March 28, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 00382903690329
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR INVESTIGATION IN SUPPORT OF THIS COMPLAINT. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY FROM EACH BATCH WERE EVALUATED BY FUNCTIONAL TESTING. 30 RETAINED SAMPLES FROM EACH BATCH WERE SENT TO FRANKLIN LAKES FOR R&D TESTING. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE R&D RETAINED SAMPLES (30) TEST RESULTS. 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. ADDITIONALLY, THE ONGOING INVESTIGATION INTO CUSTOMER CLOSURE SEPARATION (DECAPPING) FAILURES HAS MADE PROGRESS IN THE LAST FEW MONTHS. BD PERFORMED A THOROUGH INVESTIGATION INTO THIS ISSUE UTILIZING ROOT CAUSE ANALYSIS TOOLS. BD IDENTIFIED TWO POTENTIAL ROOT CAUSES, AND PRODUCT WAS MANUFACTURED UNDER DIFFERENT EXPERIMENTAL CONDITIONS TO EVALUATE THE POTENTIAL CAUSES. THE PRODUCT SAMPLES WERE TESTED TO VERIFY KEY FACTORS IN PRODUCTION THAT MAY CONTRIBUTE TO THE SEPARATION OF THE CAP FROM THE STOPPER IN AUTOMATION LINES DELIVERING TUBES TO ANALYZERS. DURING ROOT CAUSE ANALYSIS SESSIONS AND TESTING, BD IDENTIFIED OUR INTERNAL TESTING METHOD FOR STOPPER FUNCTION REQUIRED IMPROVEMENT TO BETTER REFLECT THE DYNAMICS AND FORCES SEEN AT THE DECAPPING STEP IN TUBE AUTOMATION LINES. THIS METHOD HAS BEEN RELEASED AND CONTINUES TO BE TESTED IN PARALLEL WITH HISTORIC METHODS TO VERIFY EFFECTIVENESS IN REPLICATING THE FIELD FAILURES. TO DATE IT HAS BEEN ABLE TO BETTER REFLECT THE PERFORMANCE SEEN AT OUR CUSTOMER SITES AND WE ARE MOVING TO FULLY VALIDATE IT FOR USE ON OUR DESIGN SPECIFICATIONS IN THE FUTURE. TO DATE BD HAS NOT BEEN ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE, BUT OUR R&D TEAM WILL CONTINUE TO INVESTIGATE COMPLAINTS FOR THIS DEFECT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND NO TRENDS WERE IDENTIFIED. BASED ON THE SEVERITY AND OCCURRENCE RATE OF THIS ISSUE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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. H3 OTHER TEXT : SEE H10.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3024291. MEDICAL DEVICE EXPIRATION DATE: 24-JAN-2023. DEVICE MANUFACTURE DATE: 31-MAY-2024. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES IS EXPERIENCING SHIELD SEPARATION FROM THE STOPPER. THIS HAS OCCURRED 6 TIMES EACH WITH THE LOTS 2304782 AND 3024291.
IT WAS REPORTED THAT THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES IS EXPERIENCING SHIELD SEPARATION FROM THE STOPPER. THIS HAS OCCURRED 6 TIMES EACH WITH THE LOTS 2304782 AND 3024291.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1060646 | BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 2304782 | 00382903690329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |