MAUDE manufacturer profile
RETRACTABLE TECHNOLOGIES, INC. · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | RETRACTABLE TECHNOLOGIES, INC. |
|---|---|
| Manufacturer group | JUMIN BIO-TECHNOLOGIES, CO LTD |
| 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 Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Retraction Problem, Insufficient Information, Detachment of Device or Device Component, Fail-Safe Did Not Operate, Pain, Needle Stick/Puncture 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