MAUDE manufacturer profile
ARROW INTERNATIONAL INC. · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | ARROW INTERNATIONAL INC. |
|---|---|
| Manufacturer group | ARROW INTERNATIONAL CR, A.S. |
| Product code | FMI |
| Product code name | Needle, Hypodermic, Single Lumen |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Crack, Leak/Splash, Break, Material Separation, Laceration(s), Blood Loss, Device Embedded In Tissue or Plaque 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