BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2019-01500
- Event Type
- Malfunction
- Date Received
- December 19, 2019
- Date of Event
- September 23, 2019
- Report Date
- January 13, 2020
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903664448
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2019.
H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED DURING BD TESTING, THE TUBES UNDER FILLED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 26 SEPARATE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. IRRADIATION DOSE (KGY): NOMINAL 20.4-22.6. TEST INTERVAL (MONTHS): T=19.
IT WAS REPORTED DURING BD TESTING, THE TUBES UNDER FILLED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 26 SEPARATE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. IRRADIATION DOSE (KGY): NOMINAL 20.4-22.6 TEST INTERVAL (MONTHS): T=19.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED DURING BD TESTING, THE TUBES UNDER FILLED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 26 SEPARATE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PART OF CAPA (B)(4), WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. IRRADIATION DOSE (KGY): NOMINAL 20.4-22.6 TEST INTERVAL (MONTHS): T=19.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294784 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 366444 | 8036515 | 50382903664448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |