MAUDE manufacturer profile

BAXTER HEALTHCARE - AIBONITO · KPE

MAUDE profile for Container, I.V.

Key facts

Manufacturer BAXTER HEALTHCARE - AIBONITO
Manufacturer group BAXTER HEALTHCARE - AIBONITO
Product code KPE
Product code name Container, I.V.

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Patient Involvement, Device Contamination with Chemical or Other Material, Fluid/Blood Leak, No Known Impact Or Consequence To Patient, Failure to Disconnect, No Consequences Or Impact To Patient, Break, Detachment of Device or Device Component 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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