FDA Adverse Event
Malfunction
Summary report: N
NEONATE PICC
MDR report key: 2051886
·
Received April 4, 2011
Report
- Report Number
- 2051886
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 1, 2011
- Report Date
- April 4, 2011
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
Narratives
Description of Event or Problem · 1
DURING DRESSING CHANGE NURSE FOUND THAT PICC CATHETER HAD BROKEN. X-RAY REVEALED CATHETER IN LEG UP TO MIDBACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEONATE PICC | CATHETER, PICC | LJS | ARGON MEDICAL DEVICES | * | 1013171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 DAY | NO OTHER THERAPIES |