FDA Adverse Event
Other
Summary report: N
SAF-T-INTIMA SHIELDED IV CATHETER
MDR report key: 1358753
·
Received April 8, 2009
Report
- Report Number
- 9610847-2009-00013
- Event Type
- Other
- Date Received
- April 8, 2009
- Date of Event
- March 12, 2009
- Report Date
- March 12, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USED SAMPLE WAS RECEIVED ON 03/19/2009, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).
Description of Event or Problem · 1
AFTER INSERTION OF IV CATHETER, WHILE WITHDRAWING THE NEEDLE WITH THE STYLET, THE NEEDLE PIERCED THROUGH THE TUBING AND STUCK EMPLOYEE IN THE LEFT INDEX FINGER.
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 | 8297288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |