MAUDE manufacturer profile

COVIDIEN · FMI

MAUDE profile for Needle, Hypodermic, Single Lumen

Key facts

Manufacturer COVIDIEN
Manufacturer group COVIDIEN
Product code FMI
Product code name Needle, Hypodermic, Single Lumen

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, No Patient Involvement, Fluid/Blood Leak, No Consequences Or Impact To Patient, Crack, Break, Needle Stick/Puncture, Device Contamination with Chemical or Other Material 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

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