B. Braun Medical Industries, Sdn. Bhd - March 18, 2016
Issue Date
Mar 18, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Juergen Schloesser
Contact Title
Senior Vice President Operations and Head of Center ofExcellence IV Access
Address 1
BayanLepas Free Industrial Zone
City
Penang
Zip/Postal Code
10810
Country
Malaysia
Inspection Range
Mar 14, 2016 - Mar 18, 2016
Pages
5
First Observation
Design Input and Output activities for the Introcan Safety Catheter and Introcan Safety Catheter 3 did not include adequate assessments.
Investigator(s): Ashley A. Mutawakkil