FDA Adverse Event
Malfunction
Summary report: N
BD FIRST PICC
MDR report key: 2495622
·
Received February 23, 2012
Report
- Report Number
- 2495622
- Event Type
- Malfunction
- Date Received
- February 23, 2012
- Date of Event
- February 20, 2012
- Report Date
- February 23, 2012
- Manufacturer
- BD
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE UMBILICAL ARTERIAL CATHETER (UAC) WAS FOUND BROKEN IN THE INFANT'S BED. BOTH PIECES RETRIEVED WITHOUT ANY HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD FIRST PICC | CATHETER, UMBILICAL | FOS | BD | * | 1066289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 DA |