FDA Adverse Event
Injury
Summary report: N
GRIPPER MICRO NEEDLE
MDR report key: 1941772
·
Received December 20, 2010
Report
- Report Number
- 2183502-2010-00614
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- November 26, 2010
- Report Date
- December 18, 2010
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- FPA
- PMA / PMN Number
- K072059
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN RETURNED FOR EVALUATION BUT THE EVALUATION IS NOT COMPLETE AT THIS TIME. WHEN THE EVALUATION IS COMPLETE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING NEEDLESTICK INJURY THAT OCCURRED AT THE USER FACILITY. AT THE CONCLUSION OF AN INFUSION, THE NURSE ACTIVATED THE SAFETY FEATURE OF THE DEVICE. THE DEVICE WAS NOT CAPTURED AND THE NURSE WAS STUCK BY THE EXPOSED NEEDLE. THE CLINICIAN REPORTEDLY UNDERWENT TESTING CONSISTENT WITH BLOOD EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRIPPER MICRO NEEDLE | FPA - SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | UNK | 114X39 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |