MAUDE manufacturer profile
BECTON, DICKINSON & CO. (SPARKS) · OOI
MAUDE profile for Real Time Nucleic Acid Amplification System
Key facts
| Manufacturer | BECTON, DICKINSON & CO. (SPARKS) |
|---|---|
| Manufacturer group | BECTON, DICKINSON & CO. (SPARKS) |
| Product code | OOI |
| Product code name | Real Time Nucleic Acid Amplification System |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Positive Result, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient, Structural Problem, False Negative Result, No Patient Involvement, Device Fell 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