MAUDE manufacturer profile

BAXTER HEALTHCARE - AIBONITO · FMG

MAUDE profile for Stopcock, I.V. Set

Key facts

Manufacturer BAXTER HEALTHCARE - AIBONITO
Manufacturer group BAXTER HEALTHCARE - AIBONITO
Product code FMG
Product code name Stopcock, I.V. Set

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Disconnection, No Consequences Or Impact To Patient, Fluid/Blood Leak, No Patient Involvement, Break, Crack, Reflux within Device 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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