BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2020-01081
- Event Type
- Malfunction
- Date Received
- December 30, 2020
- Date of Event
- December 7, 2020
- Report Date
- February 27, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 1/4/2021 H.6. INVESTIGATION: BD RECEIVED 10 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. THE FILL-LINE ON THESE TUBES IS A GUIDE TO THE MINIMUM FILL, SO THE DRAW SHOULD BE WELL ABOVE THE LINE UNTIL APPROACHING THE EXPIRY DATE. 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. BD WAS NOT ABLE TO IDENTIFIED A ROOT CAUSE FOR THE INDICATED FAILURE MODE. SEE H.10.
THE FOLLOWING FIELDS WERE UPDATED: H6. MEDICAL DEVICE PROBLEM CODE: A140302 - OVERFILL COMPONENT CODE: G04134 - TUBE TYPE OF INVESTIGATION: B02 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER B03 - TESTING OF DEVICE FROM SAME LOT/BATCH RETURNED FROM USER B11 - HISTORICAL DATA ANALYSIS B14 - ANALYSIS OF PRODUCTION RECORDS B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY INVESTIGATION FINDINGS: C19 - NO DEVICE PROBLEM FOUND INVESTIGATION CONCLUSION: D14 - NO PROBLEM DETECTED H6. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES AND 1 PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. EVALUATION OF THE PHOTOGRAPH INDICATES TUBES IN A HORIZONTAL POSITION, WHICH DOES NOT ALLOW TO SEE HOW MUCH BLOOD IS INSIDE THE TUBE. 10 RETURNED AND 20 RETAINED SAMPLES WERE DRAW TESTED. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 30 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE RETURNED AND RETAINED SAMPLES TEST RESULTS AND PHOTOGRAPH. THE FILL-LINE ON THESE TUBES IS A GUIDE TO THE MINIMUM FILL, SO THE DRAW SHOULD BE WELL ABOVE THE LINE UNTIL APPROACHING THE EXPIRY DATE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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.
H.6. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES AND 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. EVALUATION OF THE PHOTOGRAPHS INDICATES AN ACCEPTABLE DRAW VOLUME IN THE TUBE. A COPY OF BDS CITRATE TUBE DRAW VOLUME GUIDE IS PROVIDED TO THE CUSTOMER TO SHOW THE POSITION OF ACCEPTABLE FILL ON THE TUBE. ALTHOUGH THERE IS A SMALL VARIATION APPARENT IN THE DRAW VOLUMES, THESE DIFFERENCES FALL WITHIN THE EFFECTIVE RANGE OF THE TUBE. 10 RETURNED AND 20 RETAINED SAMPLES WERE DRAW TESTED. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 30 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE RETURNED AND RETAINED SAMPLES TEST RESULTS AND PHOTOGRAPHS ATTACHED. THE FILL-LINE ON THESE TUBES IS A GUIDE TO THE MINIMUM FILL, SO THE DRAW SHOULD BE WELL ABOVE THE LINE UNTIL APPROACHING THE EXPIRY DATE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES IN CLINICAL STUDY IT WAS DISCOVERED THAT THE TUBES ARE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CLINICAL STUDY SITE NOTICING HIGH VARIABILITY IN FILL VOLUME OF CITRATE TUBES, LATEST LOT PERCEIVED AS OVERFILLED; PT RESULTS VARIABILITY FOR ONE PATIENT WITH DIFFERENT TUBE LOTS.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES IN CLINICAL STUDY IT WAS DISCOVERED THAT THE TUBES ARE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CLINICAL STUDY SITE NOTICING HIGH VARIABILITY IN FILL VOLUME OF CITRATE TUBES, LATEST LOT PERCEIVED AS OVERFILLED; PT RESULTS VARIABILITY FOR ONE PATIENT WITH DIFFERENT TUBE LOTS.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES IN CLINICAL STUDY IT WAS DISCOVERED THAT THE TUBES ARE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CLINICAL STUDY SITE NOTICING HIGH VARIABILITY IN FILL VOLUME OF CITRATE TUBES, LATEST LOT PERCEIVED AS OVERFILLED; PT RESULTS VARIABILITY FOR ONE PATIENT WITH DIFFERENT TUBE LOTS.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES IN CLINICAL STUDY IT WAS DISCOVERED THAT THE TUBES ARE OVER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CLINICAL STUDY SITE NOTICING HIGH VARIABILITY IN FILL VOLUME OF CITRATE TUBES, LATEST LOT PERCEIVED AS OVERFILLED; PT RESULTS VARIABILITY FOR ONE PATIENT WITH DIFFERENT TUBE LOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1563748 | BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 0240225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |