BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Report
- Report Number
- 1917413-2019-01389
- Event Type
- Malfunction
- Date Received
- April 25, 2019
- Date of Event
- April 6, 2019
- Report Date
- May 21, 2019
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903627535
- PMA / PMN Number
- K891407
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#373360. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#373360. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA#373360 TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.
MATERIAL NO: 362753, BATCH NO: 8243894. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE CPT'S GRANULOCYTE CONTAMINATION RATE ROSE TO 50-55% COMPARED TO 15%. CUSTOMER IS ALSO EXPERIENCING HIGH LEVEL OF RBC IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THESE DAYS, AS I PREVIOUSLY MENTIONED, I USED CPT TUBES FOR PBMNC ISOLATION IN SEPTIC PATIENTS. I COMPARED THE OBTAINED DATA WITH SAMPLES ANALYZED FROM HEALTHY VOLUNTEERS. GRANULOCYTE CONTAMINATION RATE RISE TO 50-55% COMPARED TO 15%. I AM FACING ALSO A HIGH LEVEL OF RBC IN THE TUBES.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.
MATERIAL NO: 362753, BATCH NO: 8243894. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE CPT'S GRANULOCYTE CONTAMINATION RATE ROSE TO 50-55% COMPARED TO 15%. CUSTOMER IS ALSO EXPERIENCING HIGH LEVEL OF RBC IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THESE DAYS, AS I PREVIOUSLY MENTIONED, I USED CPT TUBES FOR PBMNC ISOLATION IN SEPTIC PATIENTS. I COMPARED THE OBTAINED DATA WITH SAMPLES ANALYZED FROM HEALTHY VOLUNTEERS. GRANULOCYTE CONTAMINATION RATE RISE TO 50-55% COMPARED TO 15%. I AM FACING ALSO A HIGH LEVEL OF RBC IN THE TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343442 | BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN | BLOOD SPECIMEN COLLECTION DEVICE; | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 8243894 | 50382903627535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |