FDA Adverse Event
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 1001881
·
Received February 19, 2008
Report
- Report Number
- 9610847-2008-00011
- Date Received
- February 19, 2008
- Report Date
- February 7, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS NOT AVAILABLE FOR THE INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO, HOWEVER, NO INFO WAS PROVIDED. UPON COMPLETION OF THE NO SAMPLE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CYTOSTATICS WAS BEING INFUSED THROUGH THE CATHETER AND LEAKED THROUGH THE SEPTUM WHICH COULD CAUSE HARM TO THE PT AND THE NURSE.
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 | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Other | CYTOSTATICS |