N
Patient 1
(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 8101825
- MDR report key
- 8101825
- Report number
- 9617032-2018-03106
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-07
- Date received
- 2018-11-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- BDX BRETT WILKO
- Address
- 9450 SOUTH STATE STREET SANDY UT 84070 US
- Phone
- 801-801-8015
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PAXGENE? BLOOD DNA TUBE | BLOOD SPECIMEN COLLECTION DEVICE | BECTON, DICKINSON AND COMPANY (BD) | PJE | 761165 | UNKNOWN | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-26 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED WITH THE USE OF THE PAXGENE? BLOOD DNA TUBE THERE WAS AN ISSUE WITH OVERFILL.