FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO NEEDLE WITH W/ NEEDLE PROTECTION DEVICE
MDR report key: 3881247
·
Received February 13, 2014
Report
- Report Number
- 2183502-2014-00032
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Report Date
- February 13, 2014
- Manufacturer
- SMITHS MEDICAL, INC.
- Product Code
- FMI
- Product Problem
- 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 STATING THAT DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95216 | HYPODERMIC NEEDLE-PRO NEEDLE WITH W/ NEEDLE PROTECTION DEVICE | NEEDLE, HYPODERMIC | FMI | SMITHS MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |