N
Patient 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 9672058
- MDR report key
- 9672058
- Report number
- 1036844-2020-00056
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-22
- Date received
- 2020-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JASMINE BROWN
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Phone
- 919-919-9193
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SPINAL ANESTHESIA KIT | NEEDLE, CONDUCTION, ANESTHETIC | ARROW INTERNATIONAL INC. | BSP | ASA-24103-SB | 23F18L0326 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-05 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS A BROKEN BUPIVACAINE VIAL.