PAXGENE BLOOD CCFDNA TUBE
Report
- Report Number
- 9617032-2021-00803
- Event Type
- Malfunction
- Date Received
- July 20, 2021
- Date of Event
- April 14, 2021
- Report Date
- July 22, 2021
- 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
Narratives
THIS RECORD WAS CANCELLED AS A DUPLICATE OF PR# (B)(4), MFG REPORT # 9617032-2021-00763 THAT CHANGED THE REPORTABILITY OF THIS COMPLAINT. THIS MDR SHOULD BE CONSIDERED CANCELLED FROM DT 3237875.
THIS RECORD WAS CANCELLED AND SHOULD BE UN-CANCELLED AS A DUPLICATE OF PR# 3231354, MFG REPORT # 9617032-2021-00763 THAT CHANGED THE REPORTABILITY OF THIS COMPLAINT. THIS MDR SHOULD BE CONSIDERED UN-CANCELLED FROM DT 3237875. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 4 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND CENTRIFUGATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER FUNCTION AS ALL SAMPLES MET SPECIFICATIONS. THE RETENTION SAMPLES WERE DRAWN WITH WATER AND CENTRIFUGED AT 1211G FOR 10 MINUTES. ZERO (0) 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED THE STOPPER POPPING OUT OF THE TUBE. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PAXGENE LOST CAP DURING CENTRIFUGATION DESCRIPTION: END USER REPORTED 3 OF 40 PAXGENE TUBES THAT LOST CAP DURING CENTRIFUGATION. THE STORAGE TEMPERATUR IS ACCORDING TO HB. RESOLUTION: THE END USER REPORTED THIS IS THE FIRST TIME THAT HAPPENED AND THERE ARE NO OTHER REPORTS FOR LOT 0133849, SO IT SEEMS TO BE SOMETHING RANDOM.
IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED THE STOPPER POPPING OUT OF THE TUBE. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PAXGENE LOST CAP DURING CENTRIFUGATION DESCRIPTION: END USER REPORTED 3 OF 40 PAXGENE TUBES THAT LOST CAP DURING CENTRIFUGATION. THE STORAGE TEMPERATUR IS ACCORDING TO HB. RESOLUTION: THE END USER REPORTED THIS IS THE FIRST TIME THAT HAPPENED AND THERE ARE NO OTHER REPORTS FOR LOT 0133849, SO IT SEEMS TO BE SOMETHING RANDOM.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED THE STOPPER POPPING OUT OF THE TUBE. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PAXGENE LOST CAP DURING CENTRIFUGATION DESCRIPTION: END USER REPORTED 3 OF 40 PAXGENE TUBES THAT LOST CAP DURING CENTRIFUGATION. THE STORAGE TEMPERATURE IS ACCORDING TO HB. RESOLUTION: THE END USER REPORTED THIS IS THE FIRST TIME THAT HAPPENED AND THERE ARE NO OTHER REPORTS FOR LOT 0133849, SO IT SEEMS TO BE SOMETHING RANDOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091636 | PAXGENE BLOOD CCFDNA TUBE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 0133849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |