FDA Adverse Event
Injury
Summary report: N
HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE
MDR report key: 1941757
·
Received December 20, 2010
Report
- Report Number
- 2183502-2010-00608
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 18, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.,
- Product Code
- FMI
- PMA / PMN Number
- K965017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED A NURSE RECEIVED A NEEDLE STICK. THE PATIENT RECEIVED THE MEDICATION VIA A DELTOID NEEDLE. AT THE CONCLUSION OF THE INJECTION, THE NEEDLE BROKE AWAY FROM THE SYRINGE AND FELL FROM THE PATIENT. THE NEEDLE STRUCK THE NURSE IN LEFT PALM. NO INFORMATION HAS BEEN RECEIVED REGARDING ANY MEDICAL TREATMENT TO NURSE; LABS WERE DRAWN, THE RESULTS WERE NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE | FMJ - NEEDLE, HYPODERMIC | FMI | SMITHS MEDICAL ASD, INC., | NA | 1768923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |