BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2024-00943
- Event Type
- Malfunction
- Date Received
- June 20, 2024
- Date of Event
- May 23, 2024
- Report Date
- June 27, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 30382903675259
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 25-JUN-2024. H.6. INVESTIGATION SUMMARY: BD RECEIVED 9 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT, SHOWING UNDERFILL WITH BOTH COMPLAINT LOTS. ADDITIONALLY BD RECEIVED (B)(4) SAMPLES OF LOT 3170111 FOR INVESTIGATION AND (B)(4) SAMPLES (LOT 3170111) AND 20 RETAINED SAMPLES (LOT 4046892) WERE RANDOMLY SELECTED FOR FUNCTIONAL DRAW VOLUME TESTING. THE ISSUE OF UNDERFILL WAS NOT OBSERVED. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 40 TUBES DREW WITHIN SPECIFICATION. A FURTHER 10 RETAINED SAMPLES FROM LOT NUMBER 4046892 AND 10 RETURNED SAMPLES (LOT 3170111) WERE RANDOMLY SELECTED FOR FUNCTIONAL TESTING RELATING TO STOPPER POP OFF. NONE OF THE CAP/STOPPER ASSEMBLIES POPPED OFF. 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 CANNOT BE CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL WITH REGARDS TO BOTH COMPLAINT LOTS BASED ON THE ATTACHED PHOTOGRAPHS. ALTHOUGH THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER DO INDICATE A LACK OF DRAW, THERE IS NO EVIDENCE THAT THE DEVICE WAS THE CAUSE OF THIS DEFECT. TESTING OF RETURNED AND RETAINED SAMPLES FROM THESE LOT NUMBERS DID NOT CONFIRM THE REPORTED DEFECT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BD WAS NOT ABLE TO IDENTIFY AN EXACT 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.
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4046892 D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026 H4. DEVICE MANUFACTURE DATE: 15-FEB-2024 A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED AND THE STOPPERS POPPED OFF WHEN ATTACHED TO THE HOLDER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED AND THE STOPPERS POPPED OFF WHEN ATTACHED TO THE HOLDER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1604128 | BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 3170111 | 30382903675259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |