FDA Adverse Event
Injury
Summary report: N
L-CATH
MDR report key: 13876
·
Received April 22, 1994
Report
- Report Number
- 2183502-1994-00005
- Event Type
- Injury
- Date Received
- April 22, 1994
- Date of Event
- April 21, 1994
- Report Date
- April 22, 1994
- Manufacturer
- LUTHER MEDICAL PRODUCTS, INC.
- Product Code
- DXG
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 4/21/94 L-CATH LEAKED AS EVIDENCED BY SATURATED DRESSING. UPON REMOVAL OF DRESSING, HUB DETACCHED FROM CATHETER, AND CATHETER THEN MIGRATED CEPHALAD, REQUIRING CUT-DOWN ON VESSEL IN EMERGENCY ROOM TO RETREIVE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L-CATH Implant | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | DXG | LUTHER MEDICAL PRODUCTS, INC. | LMP1238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R |