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
Fluid/Blood Leak	166	166
Break	158	160
Leak/Splash	85	85
Detachment of Device or Device Component	60	60
Patient-Device Incompatibility	58	58
Lack of Effect	41	41
Disconnection	40	40
Material Separation	31	32
Material Twisted/Bent	27	27
Material Split, Cut or Torn	25	25
Adverse Event Without Identified Device or Use Problem	25	26
Defective Component	25	27
Complete Blockage	24	24
No Flow	23	23
Packaging Problem	20	20
Device Markings/Labelling Problem	15	15
Separation Problem	14	14
Loose or Intermittent Connection	13	13
Device Contamination with Chemical or Other Material	13	13
Difficult to Remove	12	12
Failure to Advance	11	12
Fracture	11	11
Obstruction of Flow	11	11
Difficult to Insert	10	10
Contamination /Decontamination Problem	10	10
Defective Device	10	10
Connection Problem	9	9
Crack	9	9
Tear, Rip or Hole in Device Packaging	8	8
Material Fragmentation	8	8
Difficult to Advance	7	7
Failure to Deliver	7	7
Device Damaged Prior to Use	6	6
Activation, Positioning or Separation Problem	6	6
Use of Device Problem	6	6
Insufficient Flow or Under Infusion	6	6
Physical Resistance/Sticking	6	6
Device Dislodged or Dislocated	5	5
Therapeutic or Diagnostic Output Failure	5	5
Patient Device Interaction Problem	5	5
Mechanical Problem	5	5
Component Missing	5	5
Peeled/Delaminated	5	5
Product Quality Problem	5	5
Material Deformation	5	5
Unintended Movement	4	4
Unsealed Device Packaging	4	4
Separation Failure	4	4
Material Puncture/Hole	4	4
Volume Accuracy Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	663	666
No Consequences Or Impact To Patient	152	153
Foreign Body In Patient	81	82
Insufficient Information	72	72
No Known Impact Or Consequence To Patient	34	34
Awareness during Anaesthesia	27	27
Pain	21	22
No Patient Involvement	21	22
Inadequate Pain Relief	13	13
Device Embedded In Tissue or Plaque	12	12
No Information	9	9
Headache, Lumbar Puncture	7	7
Needle Stick/Puncture	7	7
Headache	6	6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	6
Abscess	5	5
Numbness	5	5
Unspecified Infection	4	4
Discomfort	4	4
Paresthesia	3	3
Respiratory Insufficiency	2	2
Anxiety	2	2
Bradycardia	2	3
Twitching	2	2
Chemical Exposure	2	2
Failure of Implant	2	2
Skin Infection	2	2
Muscle Weakness/Atrophy	2	2
Rash	1	1
Chest Pain	1	1
Confusion/ Disorientation	1	1
Spinal Column Injury	1	1
Dural Tear	1	1
Dyspnea	1	1
Foreign Body Reaction	1	1
Urethral Stenosis/Stricture	1	1
Hyperesthesia	1	1
Muscle/Tendon Damage	1	1
Undesired Nerve Stimulation	1	1
Cerebrospinal Fluid Leakage	1	1
Therapeutic Response, Decreased	1	1
Underdose	1	1
No Code Available	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

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL, LLC	I	Jun-13-2026
2	Arrow International Inc	II	Aug-13-2020
3	Arrow International Inc	II	Feb-14-2020
4	Arrow International Inc	II	Jan-24-2020
5	B Braun Medical Inc	II	May-29-2026
6	Becton Dickinson & Company	I	May-29-2026
7	ICU Medical Inc.	II	Jan-15-2026
8	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
9	Smiths Medical ASD Inc.	II	Apr-29-2020