FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION
MDR report key: 3966649
·
Received June 2, 2014
Report
- Report Number
- 2183502-2014-00362
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Report Date
- May 31, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- FMJ
- PMA / PMN Number
- K923127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: 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 STATING THAT DURING AN INJECTION THE NEEDLE BECAME DETACHED FROM THE SYRINGE. NO NEEDLE-STICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322534 | HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION | MANOMETER, SPINAL-FLUID | FMJ | SMITHS MEDICAL MD, INC. | NA | 2436025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |