FDA Adverse Event
Malfunction
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 1121124
·
Received August 14, 2008
Report
- Report Number
- 1710034-2008-00105
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 1, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS - A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED, AS THE SAMPLE WAS NOT RETURNED FOR THE INVESTIGATION. THE DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN. CAPA WAS COMPLETED TO IMPROVE THE EXTENSION SET BONDING PROCESS AND REDUCE THE OCCURRENCE OF LEAKS/TUBING SEPARATION. DATE SUBMITTED: 13 AUGUST 2008.
Description of Event or Problem · 1
THE EXTENSION SET BECAME DISCONNECTED FROM THE INSERTER OF THE NEXIVA CATHETER.
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 |