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, 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
Fluid/Blood Leak	137	137
Break	132	132
Leak/Splash	85	85
Patient-Device Incompatibility	56	56
Detachment of Device or Device Component	55	55
Lack of Effect	36	36
Disconnection	31	31
Material Separation	26	26
Defective Component	23	23
No Flow	22	22
Material Twisted/Bent	21	21
Packaging Problem	21	21
Complete Blockage	20	20
Material Split, Cut or Torn	15	15
Adverse Event Without Identified Device or Use Problem	13	13
Device Contamination with Chemical or Other Material	13	13
Contamination /Decontamination Problem	13	13
Device Markings/Labelling Problem	13	13
Defective Device	13	13
Separation Problem	12	12
Loose or Intermittent Connection	12	12
Failure to Advance	11	11
Difficult to Remove	11	11
Difficult to Insert	10	10
Physical Resistance/Sticking	10	10
Connection Problem	9	9
Fracture	8	8
Material Fragmentation	8	8
Obstruction of Flow	7	7
Component Missing	7	7
Therapeutic or Diagnostic Output Failure	7	7
Tear, Rip or Hole in Device Packaging	7	7
Difficult to Advance	7	7
Material Puncture/Hole	6	6
Device Damaged Prior to Use	6	6
Crack	6	6
Use of Device Problem	6	6
Mechanical Problem	6	6
Insufficient Flow or Under Infusion	6	6
Product Quality Problem	5	5
Failure to Deliver	5	5
Patient Device Interaction Problem	5	5
Device Dislodged or Dislocated	5	5
Activation, Positioning or Separation Problem	5	5
Unintended Movement	4	4
Separation Failure	4	4
Difficult to Flush	4	4
Volume Accuracy Problem	4	4
Material Deformation	4	4
Blocked Connection	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	526	526
No Consequences Or Impact To Patient	152	152
Insufficient Information	59	59
Foreign Body In Patient	46	46
No Known Impact Or Consequence To Patient	34	34
No Patient Involvement	21	21
Pain	20	20
Awareness during Anaesthesia	20	20
Device Embedded In Tissue or Plaque	11	11
No Information	9	9
Inadequate Pain Relief	9	9
Headache, Lumbar Puncture	7	7
Needle Stick/Puncture	6	6
Headache	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Discomfort	3	3
Numbness	3	3
Abscess	3	3
Failure of Implant	2	2
Muscle Weakness	2	2
Chemical Exposure	2	2
Twitching	2	2
Bradycardia	2	2
Anxiety	2	2
Urinary Tract Infection	1	1
Nervous System Injury	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Therapeutic Effects, Unexpected	1	1
Cerebrospinal Fluid Leakage	1	1
Therapeutic Response, Decreased	1	1
Underdose	1	1
Undesired Nerve Stimulation	1	1
Hyperesthesia	1	1
Dyspnea	1	1
Chest Pain	1	1
Rash	1	1
Confusion/ Disorientation	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
Nausea	1	1
No Code Available	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	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
5	Smiths Medical ASD Inc.	II	Apr-29-2020