N
Patient 1
MAUDE MDR 7240671
- MDR report key
- 7240671
- Report number
- 7240671
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-19
- Date received
- 2018-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PENCAN? | SPINAL ANESTHESIA KIT | B. BRAUN MEDICAL INC. | OFU | 333851 | 333851 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-05 | 0 |
Event Narratives#
D
Patient 1
DURING INSERTION OF THE SPINAL NEEDLE, IT BROKE OFF AND A PIECE WAS RETAINED. UNABLE TO SAFELY RETRIEVE. PATIENT WAS ABOUT TO RECEIVE SPINAL ANESTHESIA. I BELIEVE IT WAS AT THE L4/L5 LEVEL. THE DISTAL PORTION OF THE NEEDLE WAS NOTED TO BE MISSING UPON REMOVAL. IT WAS A DIFFICULT INSERTION BUT THE PROCEDURE WAS SUCCESSFUL. NOT NOTED UNTIL PROCEDURE WAS COMPLETE AND NEEDLE WAS REMOVED.