MAUDE manufacturer profile
SMITHS MEDICAL ASD, INC. · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | SMITHS MEDICAL ASD, INC. |
|---|---|
| Manufacturer group | SMITHS MEDICAL ASD, INC. |
| Product code | FMI |
| Product code name | Needle, Hypodermic, Single Lumen |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Detachment Of Device Component, Fluid/Blood Leak, Detachment of Device or Device Component, No Known Impact Or Consequence To Patient, Protective Measures Problem, Loose or Intermittent Connection Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1