FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1131263
·
Received August 12, 2008
Report
- Report Number
- 1710034-2008-00102
- Event Type
- Other
- Date Received
- August 12, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 22, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS BEING RETURNED FOR THE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER WAS PLACED IN 2008 IN THE LEFT ANTECUBITAL. THE CATHETER DID NOT FLUSH PROPERLY AND THE NURSE REMOVED THE CATHETER WITH DIFFICULTY. THE NURSE NOTICED THAT A PIECE OF THE CATHETER BROKE OFF IN THE PT'S ARM. A CT SCAN WAS COMPLETED AND CONFIRMED THE 4 MM PIECE OF CATHETER IN THE ARM. A SURGEON WAS CALLED AND REMOVED THE CATHETER SUCCESSFULLY.
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, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Other |