FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1056132
·
Received April 10, 2008
Report
- Report Number
- 1710034-2008-00042
- Event Type
- Other
- Date Received
- April 10, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 7, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS BEING RETAINED AT THE HOSP AND WILL NOT BE RELEASED. REP UNITS WERE REC'D ON 04/03/2008. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER CAME APART FROM THE ADAPTER AND REMAINED IN THE PT. THEY WERE UNABLE TO REMOVE THE CATHETER, SO AN INTERVENTIONAL RADIOLOGIST WAS CALLED TO REMOVE THE FRAGMENT THAT WAS INSIDE THE PT IN 2008. A CUT DOWN HAD TO BE PERFORMED TO REMOVE THE FRAGMENT. THERE WAS NO EXTRA HOSPITALIZATION REQUIRED AS A RESULT OF THE INCIDENT.
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 | 7353305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |