FDA Adverse Event
Injury
Summary report: N
L-CATH CATHETER SYSTEM
MDR report key: 285007
·
Received July 6, 2000
Report
- Report Number
- 1710034-2000-00028
- Event Type
- Injury
- Date Received
- July 6, 2000
- Date of Event
- May 30, 2000
- Report Date
- July 3, 2000
- Manufacturer
- BD MEDICAL SYSTEMS
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING AN X-RAY FOR AN UNRELATED PROCEDURE, A 3CM PIECE OF A CATHETER WAS FOUND IN A BABIES RIGHT LEG. THE CATHETER WAS SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L-CATH CATHETER SYSTEM | PERCUTANEOUS CATHETER | DQO | BD MEDICAL SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Required Intervention |