Anesthesia Conduction Kit

Device Code: 94

Product Code(s): CAZ

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

Device Classification Information

Device Type ID	94
Device Name	Anesthesia Conduction Kit
Physical State	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
Technical Method	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
Target Area	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
Regulation Description	Anesthesia Conduction Kit.
Regulation Medical Specialty	Anesthesiology
Review Panel	Anesthesiology
Premarket Review	Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)
Submission Type	510(k)
CFR Regulation Number	868.5140 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	CAZ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

1-79 ISO 26825 First Edition 2008-08-15
Anaesthetic And Respiratory Equipment - User-applied Labels For Syringes Containing Drugs Used During Anaesthesia - Colours, Design And Performance
5-108 ISO 80369-6 First Edition 2016-03-15
Small Bore Connectors For Liquids And Gases In Healthcare Applications - Part 6: Connectors For Neuraxial Applications.

Total Product Life Cycle

Device Type ID	94
Device	Anesthesia Conduction Kit
Product Code	CAZ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Anesthesia Conduction Kit.
CFR Regulation Number	868.5140 [🔎]

Premarket Reviews
Manufacturer	Decision
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Break	161
Adverse Event Without Identified Device Or Use Problem	146
Defective Device	125
Bent	89
Catheter	71
Difficult To Advance	68
Leak / Splash	65
Physical Resistance	56
Fluid Leak	47
Material Fragmentation	41
Infusion Or Flow Problem	39
Fracture	35
Needle	34
Insufficient Information	33
Obstruction Of Flow	27
Unknown (for Use When The Device Problem Is Not Known)	24
Difficult To Remove	23
Patient Device Interaction Problem	22
Device Handling Problem	20
Missing Value Reason	20
Device Contamination With Chemical Or Other Material	19
Partial Blockage	18
Torn Material	17
Kinked	17
Output Problem	16
Crack	16
Material Separation	16
Sticking	15
Appropriate Term/Code Not Available	15
Detachment Of Device Component	14
Difficult To Insert	14
Failure To Deliver	13
Device Operates Differently Than Expected	11
Product Quality Problem	11
Loose Or Intermittent Connection	10
Detachment Of Device Or Device Component	10
Failure To Infuse	10
Physical Resistance / Sticking	10
Material Too Rigid Or Stiff	9
Improper Or Incorrect Procedure Or Method	9
Activation, Positioning Or Separation Problem	9
Material Integrity Problem	8
Material Deformation	8
Entrapment Of Device	8
Device Or Device Fragments Location Unknown	7
Nonstandard Device	7
Device-Device Incompatibility	7
Device Contaminated During Manufacture Or Shipping	6
Split	6
Dull, Blunt	6
Defective Component	6
Tip	6
Connection Problem	6
Syringe	6
Material Frayed	6
Connector	5
Stretched	5
Cut In Material	5
Knife	5
Device Misassembled During Manufacturing / Shipping	5
Air Leak	4
Failure To Align	4
Disconnection	4
Manufacturing, Packaging Or Shipping Problem	4
No Flow	4
Deformation Due To Compressive Stress	4
Difficult To Flush	4
Failure To Advance	4
Uncoiled	4
Tear, Rip Or Hole In Device Packaging	3
Material Puncture / Hole	3
Material Split, Cut Or Torn	3
Degraded	3
Coiled	3
Occlusion Within Device	3
Unraveled Material	3
Chemical Problem	3
Material Rupture	3
Insufficient Flow Or Under Infusion	3
Device Damaged Prior To Use	3
Filter	3
Complete Blockage	3
Device Issue	3
Fitting Problem	3
Component Or Accessory Incompatibility	2
Human Factors Issue	2
Mechanical Jam	2
Component Incompatible	2
Probe	2
Difficult To Position	2
Positioning Problem	2
Shipping Damage Or Problem	2
Use Of Device Problem	2
Difficult To Open Or Close	2
Physical Property Issue	2
Therapeutic Or Diagnostic Output Failure	2
Compatibility Problem	2
Patient-Device Incompatibility	2
Device, Or Device Fragments Remain In Patient	2
Tee	2
Total Device Problems	1656

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	May-30-2018
2	Arrow International Inc	II	Feb-10-2015
3	Arrow International Inc	II	Dec-12-2014
4	Arrow International Inc	II	Oct-22-2014
5	B. Braun Medical, Inc.	II	Oct-21-2015
6	Becton Dickinson & Company	II	Nov-10-2016
7	Integra LifeSciences Corp. D.b.a. Integra Pain Management	II	Sep-21-2016
8	Integra LifeSciences Corp. D.b.a. Integra Pain Management	II	Aug-29-2016

TPLC Last Update: 2019-04-02 19:28:53