FDA Adverse Event
Other
Summary report: N
L-CATH PICC
MDR report key: 2110087
·
Received May 20, 2011
Report
- Report Number
- 1625425-2011-00072
- 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
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
LINE WOULD NOT COME OUT OF PATIENT AFTER MULTIPLE ATTEMPTS, INCLUDING WARM COMPRESS AND WAITING BETWEEN ATTEMPTS. LINES WAS STUCK IN BABY (SAPHENOUS VEIN). LINE HAD TO BE REMOVED BY VASCULAR SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L-CATH PICC | LJS | ARGON MEDICAL DEVICES, INC. | NA | 0112740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 DA | Required Intervention |