MAUDE report

MAUDE report 33764: SORENSON CUSTOM SAFESET ARTERIAL LINE KIT

Malfunction · received Jun 27, 1996 · CRITICAL CARE SYSTEMS DIV. ABBOTT LABORATORIES

Key facts

MDR report key 33764
Report number MW1009381
Event type Malfunction
Brand name SORENSON CUSTOM SAFESET ARTERIAL LINE KIT
Catalog number 46068-45
Manufacturer CRITICAL CARE SYSTEMS DIV. ABBOTT LABORATORIES
Product code DRS
Device class Class II
Date received by FDA Jun 27, 1996
Report date Jun 15, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • No 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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