FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1003827
·
Received February 26, 2008
Report
- Report Number
- 1710034-2008-00025
- Event Type
- Other
- Date Received
- February 26, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 14, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SENT A PREPAID MAILING TUBE AND LABEL TO THE CUSTOMER FOR THE RETURN OF THE SAMPLE ON 21 FEBRUARY, 2008. ADDITIONAL INFORMATION HAS ALSO BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER SEPARATED FROM THE ADAPTER.
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 |