TPLC - Total Product Life Cycle

• Device: anesthesia conduction kit
• Regulation Description: Anesthesia conduction kit.
• Definition: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Product Code: CAZ
• Regulation Number: 868.5140
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	14
ATRION MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
	SUBSTANTIALLY EQUIVALENT WITH DRUG	1
BD
	SUBSTANTIALLY EQUIVALENT	1
BUSSE HOSPITAL DISPOSABLES, INC.
	SUBSTANTIALLY EQUIVALENT	1
EPIMED
	SUBSTANTIALLY EQUIVALENT	1
HDC CORP.
	SUBSTANTIALLY EQUIVALENT	2
KENDALL
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT - KIT	3
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	2
	SUBSTANTIALLY EQUIVALENT WITH DRUG	1
LIFE-TECH INT'L., INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
MONAGHAN MEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH
	SUBSTANTIALLY EQUIVALENT	11
PORTEX, INC.
	SUBSTANTIALLY EQUIVALENT	2
SMITHS
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
TRINITY
	SUBSTANTIALLY EQUIVALENT - KIT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	74
Unknown (for use when the device problem is not known)	71
Material separation	65
Device, or device fragments remain in patient	39
Material fragmentation	35
Difficult to remove	33
Unraveled material	26
Detachment of device component	19
Component(s), broken	14
Fluid leak	14
Fracture	14
Needle, separation	13
Entrapment of device or device component	11
Material frayed	10
Device operates differently than expected	10
Tip breakage	8
Other (for use when an appropriate device code cannot be identified)	7
Detachment of device or device component	7
Air leak	7
Kinked	6
Use of Device Issue	6
Improper or incorrect procedure or method	6
Leak	6
Sticking	5
Explanted	5
Hole in material	5
Device, removal of (non-implant)	4
Cut in material	3
Device Issue	3
Difficult to deploy	3
Difficult to advance	2
No Known Device Problem	2
Physical resistance	2
Device or device fragments location unknown	2
Dislodged or dislocated	2
Resistance, loss of	2
Device-device incompatibility	2
Failure to advance	2
Failure to obtain samples	2
Blockage within device or device component	2
Decoupling	1
Disengaged	1
Knotted	1
Sharp/jagged/rough/etched/scratched	1
Material integrity issue	1
Stretched	1
Intra-cavity procedure, fiberoptic break or fragmentation during	1
Mechanical issue	1
Material puncture	1
Torn material	1
Component missing	1
Catheter withdrawal interference	1
Human-Device Interface Issue	1
Device handling issue	1
Migration of device or device component	1
Foreign material	1
Out-of-box failure	1
Material Distortion	1
Failure, intermittent	1
Occlusion within device	1
Failure to disconnect	1
Total Device Problems	570

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	0	4	0	0
Class III	0	0	0	0	0	1	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Nov-30-2011
2	Arrow International Inc	II	Jul-29-2011
3	Arrow International Inc	II	Feb-17-2011
4	Arrow International Inc	II	Feb-01-2011
5	Integra Life Sciences Corporation	II	Sep-21-2009
6	Integra LifeSciences Corp. d.b.a. Integra Pain Management	III	Jul-05-2012