FDA Adverse Event
Malfunction
Summary report: N
RACZ TUN-L-XL
MDR report key: 173302
·
Received June 16, 1998
Report
- Report Number
- 1316297-1998-00004
- Event Type
- Malfunction
- Date Received
- June 16, 1998
- Date of Event
- June 3, 1998
- Report Date
- June 15, 1998
- Manufacturer
- EPIMED INTERNATIONAL
- Product Code
- BSO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN HAD DIFFICULTY THREADING CATHETER INTO EPIDURAL SPACE. WHEN HE ATTEMPTED TO PULL CATHETER OUT THROUGH EPIDURAL NEEDLE, THE CATHETER CAUGHT AND SHEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RACZ TUN-L-XL | EPIDURAL CATHETER | BSO | EPIMED INTERNATIONAL | 155-2540 | 101097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |