TPLC - Total Product Life Cycle

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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
ARROW INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	176	178
Fluid/Blood Leak	163	163
Leak/Splash	90	90
Detachment of Device or Device Component	64	64
Patient-Device Incompatibility	58	58
Lack of Effect	41	41
Disconnection	39	39
Material Separation	36	37
Material Twisted/Bent	28	28
Defective Component	27	29
Complete Blockage	25	25
Material Split, Cut or Torn	25	25
Adverse Event Without Identified Device or Use Problem	24	25
No Flow	22	22
Packaging Problem	21	21
Device Markings/Labelling Problem	15	15
Loose or Intermittent Connection	15	15
Difficult to Remove	15	15
Contamination /Decontamination Problem	15	15
Separation Problem	14	14
Defective Device	14	14
Physical Resistance/Sticking	13	13
Device Contamination with Chemical or Other Material	13	13
Failure to Advance	12	13
Fracture	11	11
Therapeutic or Diagnostic Output Failure	11	11
Obstruction of Flow	10	10
Difficult to Insert	10	10
Crack	9	9
Connection Problem	9	9
Material Fragmentation	9	9
Tear, Rip or Hole in Device Packaging	8	8
Difficult to Advance	7	7
Insufficient Flow or Under Infusion	7	7
Component Missing	7	7
Failure to Deliver	7	7
Mechanical Problem	6	6
Device Damaged Prior to Use	6	6
Material Puncture/Hole	6	6
Use of Device Problem	6	6
Product Quality Problem	5	5
Material Deformation	5	5
Peeled/Delaminated	5	5
Activation, Positioning or Separation Problem	5	5
Device Dislodged or Dislocated	5	5
Patient Device Interaction Problem	5	5
Partial Blockage	4	4
Blocked Connection	4	4
Material Frayed	4	4
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	644	647
No Consequences Or Impact To Patient	152	153
Foreign Body In Patient	72	73
Insufficient Information	70	70
No Known Impact Or Consequence To Patient	34	34
Awareness during Anaesthesia	26	26
No Patient Involvement	21	22
Pain	20	21
Device Embedded In Tissue or Plaque	12	12
Inadequate Pain Relief	11	11
No Information	9	9
Headache, Lumbar Puncture	7	7
Needle Stick/Puncture	7	7
Headache	6	6
Abscess	5	5
Unspecified Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	5
Paresthesia	3	3
Discomfort	3	3
Numbness	3	3
Failure of Implant	2	2
Muscle Weakness	2	2
Chemical Exposure	2	2
Twitching	2	2
Bradycardia	2	3
Anxiety	2	2
Urinary Tract Infection	1	1
Nervous System Injury	1	1
Low Oxygen Saturation	1	1
Low Blood Pressure/ Hypotension	1	2
Unspecified Vascular Problem	1	1
Loss of consciousness	1	1
Therapeutic Effects, Unexpected	1	1
Underdose	1	1
Therapeutic Response, Decreased	1	1
Cerebrospinal Fluid Leakage	1	1
Undesired Nerve Stimulation	1	1
Muscle/Tendon Damage	1	1
Hyperesthesia	1	1
Dyspnea	1	1
Chest Pain	1	1
Rash	1	1
Confusion/ Disorientation	1	1
Spinal Column Injury	1	1
Foreign Body Reaction	1	1
Urethral Stenosis/Stricture	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
No Code Available	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1

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	ICU Medical Inc.	II	Jan-15-2026
5	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
6	Smiths Medical ASD Inc.	II	Apr-29-2020