FDA Adverse Event
Injury
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 2161703
·
Received July 8, 2011
Report
- Report Number
- 1710034-2011-00057
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 8, 2011
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE EXTENSION TUBING DISCONNECTED FROM THE Y-ADAPTER DURING USE AND A NEW IV HAD TO BE STARTED.
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 | Other |