TPLC - Total Product Life Cycle

• Device: needle, conduction, anesthetic (w/wo introducer)
• Regulation Description: Anesthesia conduction needle.
• Product Code: BSP
• Regulation Number: 868.5150
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
BALLARD MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BD
	SUBSTANTIALLY EQUIVALENT	1
BUSSE HOSPITAL DISPOSABLES, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	2
EPIMED
	SUBSTANTIALLY EQUIVALENT	6
HAVEL'S, INC.
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	6
KYPHON, INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE-TECH INT'L., INC.
	SUBSTANTIALLY EQUIVALENT	3
MANAN MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
PAJUNK GMBH
	SUBSTANTIALLY EQUIVALENT	10
RUSCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIMS
	SUBSTANTIALLY EQUIVALENT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	7
Device operates differently than expected	4
Not Applicable	3
Detachment of device component	3
Fluid leak	3
Loose or intermittent connection	3
Needle, separation	2
Difficult to remove	1
Replace	1
Sticking	1
Cannula Guide, Needle Insertion Difficult	1
Material integrity issue	1
Total Device Problems	30

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	0	0	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Kyphon Inc	II	Feb-05-2008