FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1213715
·
Received October 24, 2008
Report
- Report Number
- 1710034-2008-00133
- Event Type
- Other
- Date Received
- October 24, 2008
- Date of Event
- September 28, 2008
- Report Date
- September 30, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED IN 2008, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 23 OCTOBER 2008.
Description of Event or Problem · 1
A 20 GAUGE CATHETER WAS PLACED BY EMT. THE CATHETER BEGAN TO LEAK BLOOD AND IT WAS NOTICED THAT THE CATHETER SEPARATED FROM THE ADAPTER. THE ACTUAL SAMPLE WAS SAVED FOR THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSYTE AUTOGUARD SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | LJS | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 8064226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |