BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Report
- Report Number
- 1917413-2022-00068
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Date of Event
- January 27, 2022
- Report Date
- May 16, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903627535
- PMA / PMN Number
- K891407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.10 AN ADDITIONAL LOT # WAS REPORTED. THE INFORMATION FOR THIS LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1202253 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31 H.4. DEVICE MANUFACTURE DATE: 2021-07-21
H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOTS WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER SEPARATION WERE OBSERVED. VISUAL INSPECTION SHOWED NO DEFECTS OBSERVED. ADDITIONALLY, CLINICAL TESTING WAS PERFORMED: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 IS NOT CONFIRMED WITH RESPECT TO POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
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 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY FOLLOWED ALL STANDARD PROCEDURES BUT AFTER SPINNING FOR 30 MINUTES, THE RED BLOOD CELLS DID NOT GO BELOW THE GEL LAYER. THIS HAPPENED WITH A TOTAL OF 3 TUBES ON (B)(6) 2022.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY FOLLOWED ALL STANDARD PROCEDURES BUT AFTER SPINNING FOR 30 MINUTES, THE RED BLOOD CELLS DID NOT GO BELOW THE GEL LAYER.THIS HAPPENED WITH A TOTAL OF 3 TUBES ON (B)(6) , 2022.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY FOLLOWED ALL STANDARD PROCEDURES BUT AFTER SPINNING FOR 30 MINUTES, THE RED BLOOD CELLS DID NOT GO BELOW THE GEL LAYER. THIS HAPPENED WITH A TOTAL OF 3 TUBES ON (B)(6) 2022.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY FOLLOWED ALL STANDARD PROCEDURES BUT AFTER SPINNING FOR 30 MINUTES, THE RED BLOOD CELLS DID NOT GO BELOW THE GEL LAYER. THIS HAPPENED WITH A TOTAL OF 3 TUBES ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1849490 | BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 362753 | SEE H.10 | 50382903627535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |