FDA Adverse Event
Other
Summary report: N
BD SAF-T-INTIMA SHIELDED IV CATHETER
MDR report key: 1791911
·
Received August 3, 2010
Report
- Report Number
- 9610847-2010-00027
- Event Type
- Other
- Date Received
- August 3, 2010
- Report Date
- June 22, 2010
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE NURSE WAS PLACING THE SAF-T-INTIMA ON A PATIENT THE GUIDEWIRE WAS WITHDREW IN THE USUAL WAY WHICH USUALLY RETRACTS INTO THE COVER. ON THIS OCCASION IT DID NOT RETRACT AND WAS COMPLETELY EXPOSED WHICH RESULTED IN A NEEDLE STICK INJURY TO THE NURSE'S THUMB. THE NURSE WAS EXPERIENCED IN USING THE SYSTEM AND THIS IS THE FIRST INCIDENT OF THIS NATURE USING SAF-T-INTIMA OVER A TWO YEAR PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD SAF-T-INTIMA SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 9237285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |