FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1403453
·
Received May 21, 2009
Report
- Report Number
- 1710034-2009-00096
- Event Type
- Other
- Date Received
- May 21, 2009
- Date of Event
- December 8, 2008
- Report Date
- April 29, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B) (4) CONCLUSION - A ROOT CAUSE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT RETURNED FOR THE INVESTIGATION. THE DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. (B) (4)
Description of Event or Problem · 1
NEEDLE FAILED TO RETRACT; EXTRA CARE WAS NOT EXERCISED AND A NEEDLE STICK INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSYTE AUTOGUARD SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |