FDA Adverse Event
Malfunction
Summary report: N
BD FIRST PICC
MDR report key: 2030803
·
Received March 22, 2011
Report
- Report Number
- 1625425-2011-00027
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- LJS
- PMA / PMN Number
- K945449
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
HAD ONE PICC THAT BROKE OFF IN NEONATE AND IT WILL BE REMOVED SOMETIME THIS AFTERNOON. THE SECOND INCIDENT OCCURRED THIS WEEK AND BROKE DURING INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD FIRST PICC | LJS | ARGON MEDICAL DEVICES INC. | NA | 1013171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |