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
1. K202699 E-Cath STIM acc. Tsui

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	178	180
Fluid/Blood Leak	166	166
Leak/Splash	90	90
Detachment of Device or Device Component	65	65
Patient-Device Incompatibility	58	58
Lack of Effect	42	42
Disconnection	40	40
Material Separation	36	37
Material Twisted/Bent	28	28
Defective Component	28	30
Adverse Event Without Identified Device or Use Problem	26	27
Material Split, Cut or Torn	25	25
Complete Blockage	25	25
No Flow	22	22
Packaging Problem	21	21
Loose or Intermittent Connection	15	15
Contamination /Decontamination Problem	15	15
Difficult to Remove	15	15
Device Markings/Labelling Problem	15	15
Separation Problem	14	14
Defective Device	14	14
Device Contamination with Chemical or Other Material	13	13
Physical Resistance/Sticking	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	10	10
Connection Problem	9	9
Material Fragmentation	9	9
Tear, Rip or Hole in Device Packaging	8	8
Difficult to Advance	7	7
Failure to Deliver	7	7
Use of Device Problem	7	7
Component Missing	7	7
Insufficient Flow or Under Infusion	7	7
Material Puncture/Hole	6	6
Device Damaged Prior to Use	6	6
Activation, Positioning or Separation Problem	6	6
Mechanical Problem	6	6
Device Dislodged or Dislocated	5	5
Peeled/Delaminated	5	5
Patient Device Interaction Problem	5	5
Product Quality Problem	5	5
Material Deformation	5	5
Material Frayed	4	4
Unintended Movement	4	4
Separation Failure	4	4
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	649	652
No Consequences Or Impact To Patient	152	153
Foreign Body In Patient	75	76
Insufficient Information	71	71
No Known Impact Or Consequence To Patient	34	34
Awareness during Anaesthesia	27	27
Pain	21	22
No Patient Involvement	21	22
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
Discomfort	4	4
Paresthesia	3	3
Numbness	3	3
Anxiety	2	2
Bradycardia	2	3
Twitching	2	2
Chemical Exposure	2	2
Muscle Weakness	2	2
Failure of Implant	2	2
Skin Infection	2	2
Rash	1	1
Confusion/ Disorientation	1	1
Spinal Column Injury	1	1
Foreign Body Reaction	1	1
Chest Pain	1	1
Urethral Stenosis/Stricture	1	1
Dyspnea	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
Hyperesthesia	1	1
Muscle/Tendon Damage	1	1
No Code Available	1	1
Undesired Nerve Stimulation	1	1
Cerebrospinal Fluid Leakage	1	1
Therapeutic Response, Decreased	1	1
Underdose	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Therapeutic Effects, Unexpected	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Low Blood Pressure/ Hypotension	1	2
Low Oxygen Saturation	1	1
Nervous System Injury	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	B Braun Medical Inc	II	May-29-2026
5	Becton Dickinson & Company	I	May-29-2026
6	ICU Medical Inc.	II	Jan-15-2026
7	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
8	Smiths Medical ASD Inc.	II	Apr-29-2020