FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE
MDR report key: 3173247
·
Received June 6, 2013
Report
- Report Number
- 2183502-2013-00302
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Report Date
- June 5, 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 MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR 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 BROKEN FROM THE SYRINGE AND REMAINED IN THE PATIENTS ARM. THERE WAS NO PATIENT OF CLINICIAN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251949 | HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE | NEEDLE, HYPODERMIC | FMJ | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |