FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1083455
·
Received July 21, 2008
Report
- Report Number
- 1710034-2008-00088
- Event Type
- Other
- Date Received
- July 21, 2008
- Date of Event
- June 9, 2008
- Report Date
- July 10, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS NOT AVAILABLE FOR THE INVESTIGATION. UPON COMPLETION OF THE NO SAMPLE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER KINKED DURING INSERTION INTO DORSUM OF LEFT HAND. CATHETER BROKE AND WAS SURGICALLY REMOVED FROM THE PT. THERE WAS NO HARM TO THE PT AND EXTRA HOSPITALIZATION WAS NOT 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, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |