MAUDE report

MAUDE report 3929: PORT-A-CATH NEEDLE, 20 GAUGE, 1 INCH, 90 DEGREE METAL HUB.

Malfunction · received Jul 31, 1992 · PHARMACIA DELTEC

Key facts

MDR report key 3929
Report number 3929
Event type Malfunction
Brand name PORT-A-CATH NEEDLE, 20 GAUGE, 1 INCH, 90 DEGREE METAL HUB.
Model number 520-849
Catalog number 520-849
Manufacturer PHARMACIA DELTEC
Product code GCB
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jul 31, 1992
Report date Apr 1, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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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