FDA Adverse Event
Summary report: N
SMITHS MEDICAL HYPODERMIC NEEDLE-PRO REF 4290
MDR report key: 14801000
·
Received June 23, 2022
Report
- Report Number
- MW5110488
- Date Received
- June 23, 2022
- Date of Event
- April 27, 2022
- Report Date
- June 21, 2022
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMI
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SMITHS MEDICAL HYPODERMIC NEEDLE-PRO REF 4290, LOT 4142906 COMES WITH LUERLOCK BETWEEN SAFETY AND NEEDLE WHICH IS NOT TIGHT. THIS CAUSES IM INJECTIONS TO LEAK OR SPRAY FROM HUB INSTEAD OF PT RECEIVING MED. THIS OCCURRED WITH A PT RECEIVING NOROFLEX. MD AND PHARM CONSULTED, AND AN ADDITIONAL 1/2 DOSE ORDERED AND GIVEN. SEVERAL OTHER NURSES REPORT HAVING HAD ISSUES. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608914 | SMITHS MEDICAL HYPODERMIC NEEDLE-PRO REF 4290 | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | SMITHS MEDICAL ASD, INC. | 4142906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |