FDA Adverse Event
Malfunction
Summary report: N
BREVI-XL
MDR report key: 3087180
·
Received March 25, 2013
Report
- Report Number
- 1316297-2013-00002
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- November 14, 2012
- Report Date
- March 21, 2013
- Manufacturer
- EPIMED INTERNATIONAL, INC.
- Product Code
- BSO
- PMA / PMN Number
- 954584
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO EPIMED FOR EVAL.
Description of Event or Problem · 1
AN EPIMED CATHETER WAS SHEARED BY THE INTRODUCER NEEDLE LEAVING A SMALL FRAGMENT OF THE CATHETER IN THE PT. THE HOSP STATED THAT THE PT WILL NEED TO BE FOLLOWED, AND THAT THE CATHETER FRAGMENT WAS NOT ATTEMPTED TO BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122254 | BREVI-XL | EPIDURAL CATHETER | BSO | EPIMED INTERNATIONAL, INC. | 155-2340 | 11405212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |