DeviceClearance

K201099

Substantially Equivalent

BD PhaSeal Optima Closed System Drug Transfer Device

Applicant
Becton, Dickinson and Company
Product code
ONB
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Franklin Lakes, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB
Malfunction
3,615
Other
13
Total
3,628

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.