FDA Adverse Event
Malfunction
Summary report: N
SAF-T -INTIMA SHIELDED IV CATHETER
MDR report key: 1022305
·
Received March 24, 2008
Report
- Report Number
- 9610847-2008-00022
- Event Type
- Malfunction
- Date Received
- March 24, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IS NOT AVAILABLE FROM THE CUSTOMER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
SUCCESSFUL INSERTION OF SAF-T-INTIMA CATHETER WITH GOOD BLOOD RETURN. WHEN THEY ATTEMPTED TO REMOVE THE NEEDLE, THE STYLET SEPARATED FROM THE STYLET PULLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAF-T -INTIMA SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 6158826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |