FDA Adverse Event
Malfunction
Summary report: N
PROMETRA INTRATHECAL CATHETER
MDR report key: 4200200
·
Received October 21, 2014
Report
- Report Number
- 3006803715-2014-00033
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 22, 2014
- Manufacturer
- FLOWONIX MEDICAL INC.
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TUOHY NEEDLE BROKE AT THE HUB DURING IMPLANT OF THE CATHETER. THE PT WAS REPORTEDLY OBESE SO THE NEEDLE BROKE IN THE PT'S TISSUE. THE BROKEN NEEDLE WAS REMOVED IMMEDIATELY FROM THE PT AND A DIFFERENT NEEDLE WAS USED. THERE WERE NO PT EFFECTS REPORTED. THE NEEDLE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670172 | PROMETRA INTRATHECAL CATHETER | IMPLANTABLE INTRATHECAL CATHETER | LKK | FLOWONIX MEDICAL INC. | 11823 | 19502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |