TPLC - Total Product Life Cycle

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Device	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
ARROW INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ARROW INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BECTON DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
IMD INC
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
LIFE-TECH, INC.
	SUBSTANTIALLY EQUIVALENT	3
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	3
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	3
TELEFLEX INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	514	514
Fluid/Blood Leak	281	281
Leak/Splash	192	192
Adverse Event Without Identified Device or Use Problem	160	160
Defective Device	145	145
Detachment of Device or Device Component	97	97
Bent	93	93
Difficult to Advance	82	82
Physical Resistance	78	78
Patient-Device Incompatibility	72	72
Material Fragmentation	63	63
Difficult to Remove	62	62
Infusion or Flow Problem	51	51
Material Separation	51	51
Device Contamination with Chemical or Other Material	49	49
Fracture	47	47
Insufficient Information	45	45
Detachment Of Device Component	44	44
Failure to Advance	41	41
Defective Component	40	40
Disconnection	40	40
Obstruction of Flow	40	40
Device Operates Differently Than Expected	37	37
No Flow	36	36
Loose or Intermittent Connection	34	34
Difficult to Insert	33	33
Packaging Problem	30	30
Output Problem	29	29
Material Twisted/Bent	28	28
Activation, Positioning or Separation Problem	28	28
Lack of Effect	27	27
Patient Device Interaction Problem	27	27
Kinked	26	26
Physical Resistance/Sticking	25	25
Component Missing	25	25
Crack	25	25
Device Markings/Labelling Problem	24	24
Unknown (for use when the device problem is not known)	24	24
Partial Blockage	23	23
Device Or Device Fragments Location Unknown	23	23
Appropriate Term/Code Not Available	22	22
Torn Material	21	21
Complete Blockage	21	21
Separation Problem	21	21
Device Handling Problem	20	20
Missing Value Reason	20	20
Sticking	19	19
Material Split, Cut or Torn	18	18
Material Integrity Problem	17	17
Tear, Rip or Hole in Device Packaging	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1064	1064
No Clinical Signs, Symptoms or Conditions	474	474
No Known Impact Or Consequence To Patient	406	406
Awareness during Anaesthesia	241	241
No Patient Involvement	147	147
No Information	133	133
Device Embedded In Tissue or Plaque	131	131
Foreign Body In Patient	107	107
Pain	68	68
Insufficient Information	53	53
Headache, Lumbar Puncture	34	34
No Code Available	28	28
Therapy/non-surgical treatment, additional	25	25
Patient Problem/Medical Problem	22	22
Inadequate Pain Relief	20	20
Cerebrospinal Fluid Leakage	19	19
Not Applicable	18	18
Headache	17	17
Numbness	16	16
Needle Stick/Puncture	13	13
Perforation	12	12
Infiltration into Tissue	11	11
Weakness	10	10
Blood Loss	10	10
Therapeutic Response, Decreased	6	6
Discomfort	5	5
Unspecified Infection	5	5
Paralysis	5	5
Underdose	5	5
Therapeutic Effects, Unexpected	4	4
Tingling	4	4
Complaint, Ill-Defined	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Dyspnea	4	4
Anxiety	3	3
Hematoma	3	3
Twitching	2	2
Bradycardia	2	2
Paresis	2	2
Swelling	2	2
Reaction	2	2
Laceration(s)	2	2
Injury	2	2
Incontinence	2	2
Neurological Deficit/Dysfunction	2	2
Arachnoiditis, Spinal	2	2
Surgical procedure	2	2
Failure of Implant	2	2
Skin Irritation	2	2
Nausea	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Aug-13-2020
2	Arrow International Inc	II	Feb-14-2020
3	Arrow International Inc	II	Jan-24-2020
4	Arrow International Inc	II	May-30-2018
5	Arrow International Inc	II	Feb-10-2015
6	Arrow International Inc	II	Dec-12-2014
7	Arrow International Inc	II	Oct-22-2014
8	Arrow International Inc	II	Dec-19-2013
9	Arrow International Inc	II	Nov-30-2011
10	Arrow International Inc	II	Jul-29-2011
11	Arrow International Inc	II	Feb-17-2011
12	Arrow International Inc	II	Feb-01-2011
13	B. Braun Medical, Inc.	II	Oct-21-2015
14	Becton Dickinson & Company	II	Nov-10-2016
15	Becton Dickinson & Company	II	Sep-26-2013
16	Integra Life Sciences Corporation	II	Sep-21-2009
17	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Sep-21-2016
18	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Aug-29-2016
19	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Dec-17-2013
20	Integra LifeSciences Corp. d.b.a. Integra Pain Management	III	Jul-05-2012
21	Kimberly-Clark Corporation	II	Dec-16-2013
22	Smiths Medical ASD Inc.	II	Apr-29-2020
23	Smiths Medical ASD, Inc.	II	Nov-05-2013