FDA Adverse Event
Injury
Summary report: N
JELCO NEEDLE-PRO EDGE NEEDLE
MDR report key: 1831947
·
Received September 7, 2010
Report
- Report Number
- 2183502-2010-00364
- Event Type
- Injury
- Date Received
- September 7, 2010
- Report Date
- August 19, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMI
- PMA / PMN Number
- K011925
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED A NURSE RECEIVED A NEEDLE STICK. THE REPORT STATED THAT THE NURSE ATTEMPTED TO RECAP A NEEDLE, WHEN SLIDING THE NEEDLE INWARD IT SEEMS TO CATCH FORCING THE NEEDLE TO GO THROUGH THE PLASTIC AND STICKS THE NURSE. THE REPORT DOES NOT INDICATE THAT THE STICK WAS A FAILURE OF THE SAFETY DEVICE; THE REPORT SPECIFIES THAT THE STICK OCCURRED DURING A RECAPPING ACTIVITY. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE AND NO TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JELCO NEEDLE-PRO EDGE NEEDLE | FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |