FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION
MDR report key: 3965941
·
Received June 4, 2014
Report
- Report Number
- 2183502-2014-00374
- Event Type
- Malfunction
- Date Received
- June 4, 2014
- Report Date
- June 3, 2014
- Manufacturer
- SMITHS MEDICAL, INC.
- Product Code
- FMJ
- PMA / PMN Number
- K923127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
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. (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. THERE WAS NO PT OR CLINICIAN INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327324 | HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION | NEEDLE, HYPODERMIC | FMJ | SMITHS MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |