FDA Adverse Event
Injury
Summary report: N
L CATH CATHETER SYSTEM
MDR report key: 228264
·
Received June 17, 1999
Report
- Report Number
- 2022441-1999-00008
- Event Type
- Injury
- Date Received
- June 17, 1999
- Date of Event
- April 27, 1999
- Report Date
- June 15, 1999
- Manufacturer
- LUTHER MEDICAL PRODUCTS, INC.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN 18 GAUGE PICC WAS INSERTED INTO 12 YEAR OLD FEMALE PT. THE UNIT EXHIBITED LEAKAGE WHILE PREPPING THE PT FOR REMOVAL AND RE-INSERTION OF THE CATHETER, THE DEVICE IN USE BROKE AT THE SITE. PLASTIC SURGEON CALLED AND SURGICALLY REMOVED IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L CATH CATHETER SYSTEM | CENTRAL VENOUS CATHETER | DQO | LUTHER MEDICAL PRODUCTS, INC. | NA | LMP 5205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |