FDA Adverse Event
Other
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 1002947
·
Received February 6, 2008
Report
- Report Number
- 9610847-2008-00010
- Event Type
- Other
- Date Received
- February 6, 2008
- Report Date
- January 9, 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 BEING RETURNED FOR THE INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CYTOSTATICS WERE BEING INFUSED THROUGH THE CATHETER AND LEAKED THROUGH THE SEPTUM WHICH COULD CAUSE HARM TO THE PATIENT 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 | 7142266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | CYTOSTATICS |