FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE
MDR report key: 2980212
·
Received February 1, 2013
Report
- Report Number
- 2183502-2012-00696
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- December 28, 2012
- Report Date
- January 25, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMJ
- PMA / PMN Number
- K965017
- 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 THAT STATED DURING AN INJECTION VIA A DELTOID NEEDLE, THE NEEDLE BECAME DETACHED FORM THE SYRINGE AND REMAINED IN THE PT. THE NURSE REMOVED THE DETACHED NEEDLE FROM THE PT. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45484 | HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE | FMJ - NEEDLE, HYPODERMIC | FMJ | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |