FDA Adverse Event
Other
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 1553128
·
Received December 4, 2009
Report
- Report Number
- 1710034-2009-00208
- Event Type
- Other
- Date Received
- December 4, 2009
- Date of Event
- November 12, 2009
- Report Date
- November 16, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED FROM THE REPORTER. THE SAMPLE HAS BEEN RECEIVED, UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
DEVICE LEAKED DURING CHEMOTHERAPY INFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD NEXIVA CLOSED IV ACCESS SYSTEM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. | NA | 9187219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | CHEMOTHERAPY DRUGS |