TPLC - Total Product Life Cycle

Device	stopcock, i.v. set
Regulation Description	Intravascular administration set.
Product Code	FMG
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	3
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CHURCHILL MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL A.C.A.L.
	SUBSTANTIALLY EQUIVALENT	3
HALKEY-ROBERTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL SALES, INC.
	SUBSTANTIALLY EQUIVALENT	5
INTERPORE CROSS
	SUBSTANTIALLY EQUIVALENT	1
MEDEGEN
	SUBSTANTIALLY EQUIVALENT	1
MEDEX
	SUBSTANTIALLY EQUIVALENT	3
MEDICAL DEVICE CONSULTANTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
TRISTATE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak	22
Crack	16
Fluid leak	14
Component(s), broken	14
Disconnection	4
Break	2
Normal	2
Improper or incorrect procedure or method	2
Device damaged prior to use	1
Tube(s), buckling of	1
Split	1
Incompatibility problem	1
Device, or device fragments remain in patient	1
Material separation	1
Sticking	1
Use of Device Issue	1
Air leak	1
Detachment of device component	1
Inaccurate flowrate	1
Foreign material	1
Kinked	1
Loose or intermittent connection	1
Misconnection	1
Total Device Problems	91