FDA Adverse Event
Other
Summary report: N
L-CATH PICC
MDR report key: 2110086
·
Received May 20, 2011
Report
- Report Number
- 1625425-2011-00074
- Event Type
- Other
- Date Received
- May 20, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 20, 2011
- Manufacturer
- ARGON MEDICAL DEVICES, INC.
- Product Code
- LJS
- PMA / PMN Number
- K920755
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
CATHETER BROKE OFF INSIDE (B)(6) (INSERTED (B)(4) 2011). TRANSFERRED TO CHILDREN'S HOSPITAL FOR REMOVAL AFTER X-RAY HAD SHOWN CATHETER WAS STILL INSIDE. NO DRESSING CHANGE WAS BEING DONE AT THE TIME OF THE OCCURRENCE. CARDIAC CATHETER WAS USED TO REMOVE. IT TOOK 3 ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L-CATH PICC | LJS | ARGON MEDICAL DEVICES, INC. | NA | 0281484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 DA | Required Intervention |