FDA Adverse Event
Injury
Summary report: N
EPIDURAL CATHETER BRAUN
MDR report key: 25799
·
Received January 19, 1995
Report
- Report Number
- 25799
- Event Type
- Injury
- Date Received
- January 19, 1995
- Date of Event
- September 23, 1994
- Report Date
- October 11, 1994
- Manufacturer
- BRAUN MEDICA, INC.
- Product Code
- LMP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
"PT. UNDERWENT PERCUTANEOUS PLACEMENT OF AN EPIDURAL CATHETER FOR ANESTHESIA DURING UROLOGIC PROCEDURE. AT THE TERMINATION OF THE PROCEDURE AND UPON ATTEMPTING TO RETRIEVE THE CATHETER, THE DEVICE BECAME STRETCHED AND WHEN MEASURING IT IN COMPARISON TO THE EXPECTED LENGTH IT IS SHORTER. THE PRESUMPTION IS THAT A SMALL PORTION, PERHAPS SEVERAL INCHES OF THE CATHETER WAS LEFT IN THE SUBCUTANEOUS TISSUE. NO ASSOCIATED NEUROLOGIC DEFICITS. XRAYS REVEALED NO RADIOGRAPHIC METERIAL PRESENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIDURAL CATHETER BRAUN | BURRON PERIFIX | LMP | BRAUN MEDICA, INC. | 899840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 * | Required Intervention |