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
1. K210983 BD Epilor Syringe
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	173	175
Fluid/Blood Leak	156	156
Leak/Splash	88	88
Detachment of Device or Device Component	57	57
Patient-Device Incompatibility	56	56
Lack of Effect	41	41
Disconnection	39	39
Material Separation	31	32
Material Twisted/Bent	28	28
Defective Component	27	29
Adverse Event Without Identified Device or Use Problem	24	25
Complete Blockage	24	24
Material Split, Cut or Torn	24	24
No Flow	22	22
Packaging Problem	21	21
Device Markings/Labelling Problem	15	15
Contamination /Decontamination Problem	15	15
Loose or Intermittent Connection	15	15
Separation Problem	14	14
Defective Device	14	14
Physical Resistance/Sticking	13	13
Device Contamination with Chemical or Other Material	13	13
Difficult to Remove	13	13
Failure to Advance	11	12
Therapeutic or Diagnostic Output Failure	11	11
Fracture	10	10
Difficult to Insert	10	10
Connection Problem	9	9
Crack	9	9
Obstruction of Flow	8	8
Tear, Rip or Hole in Device Packaging	8	8
Material Fragmentation	8	8
Insufficient Flow or Under Infusion	7	7
Component Missing	7	7
Difficult to Advance	7	7
Mechanical Problem	6	6
Device Damaged Prior to Use	6	6
Material Puncture/Hole	6	6
Use of Device Problem	6	6
Failure to Deliver	6	6
Device Dislodged or Dislocated	5	5
Peeled/Delaminated	5	5
Activation, Positioning or Separation Problem	5	5
Product Quality Problem	5	5
Patient Device Interaction Problem	5	5
Blocked Connection	4	4
Material Deformation	4	4
Partial Blockage	4	4
Material Integrity Problem	4	4
Material Frayed	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	619	622
No Consequences Or Impact To Patient	152	153
Foreign Body In Patient	68	69
Insufficient Information	67	67
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	5
Paresthesia	3	3
Discomfort	3	3
Numbness	3	3
Abscess	3	3
Chemical Exposure	2	2
Muscle Weakness	2	2
Twitching	2	2
Bradycardia	2	3
Anxiety	2	2
Failure of Implant	2	2
Urethral Stenosis/Stricture	1	1
Foreign Body Reaction	1	1
Spinal Column Injury	1	1
Confusion/ Disorientation	1	1
Rash	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
Chest Pain	1	1
No Code Available	1	1
Nausea	1	1
Dyspnea	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
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
Urinary Tract Infection	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