FDA Adverse Event
Malfunction
Summary report: N
BREVI-XL
MDR report key: 3072314
·
Received April 5, 2013
Report
- Report Number
- 1316297-2013-00003
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- August 8, 2012
- Report Date
- March 26, 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
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO EPIMED FOR EVAL.
Description of Event or Problem · 1
AN EPIMED CATHETER WAS SKIVED. AFTER THE DOCTOR PERFORMED SEVERAL PASSES WITH THE CATHETER IN QUESTION, THE DOCTOR FELT RESISTANCE AND REMOVED BOTH THE CATHETER AND NEEDLE TOGETHER, AND REPORTED THE ABOVE-MENTIONED INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142027 | BREVI-XL | EPIDURAL CATHETER | BSO | EPIMED INTERNATIONAL, INC. | 155-2340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |