MAUDE report

MAUDE report 16169: ARROW ARTERIAL LINE KIT

Injury · received Jul 21, 1994 · ARROW INTERNATIONAL, INC.

Key facts

MDR report key 16169
Report number 16169
Event type Injury
Brand name ARROW ARTERIAL LINE KIT
Model number AK-04510
Catalog number NI
Manufacturer ARROW INTERNATIONAL, INC.
Date received by FDA Jul 21, 1994
Report date May 4, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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