FDA Adverse Event
Summary report: N
L-CATH PICC
MDR report key: 1981790
·
Received January 19, 2011
Report
- Report Number
- 1625425-2011-00006
- Date Received
- January 19, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 20, 2010
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT ONCE COMPLETE.
Description of Event or Problem · 1
CATHETER WAS IMPLEMENTED WITH RADIOLOGICAL VERIFICATION OF THE CATHETER PLACEMENT. COMPLICATION OCCURRED 24 HOURS AFTER INSERTION. (PERFUSO-THORAX).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L-CATH PICC | L-CATH | LJS | ARGON MEDICAL DEVICES INC. | NA | 0005199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |