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
1. K222341 Arrow 0.2 Micron Flat Filter, GVS
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	169	171
Fluid/Blood Leak	154	154
Leak/Splash	88	88
Detachment of Device or Device Component	56	56
Patient-Device Incompatibility	56	56
Lack of Effect	41	41
Disconnection	36	36
Material Separation	31	32
Material Twisted/Bent	27	27
Defective Component	27	29
Adverse Event Without Identified Device or Use Problem	24	25
Material Split, Cut or Torn	24	24
Complete Blockage	23	23
No Flow	22	22
Packaging Problem	21	21
Loose or Intermittent Connection	15	15
Device Markings/Labelling Problem	15	15
Separation Problem	14	14
Contamination /Decontamination Problem	14	14
Defective Device	14	14
Device Contamination with Chemical or Other Material	13	13
Physical Resistance/Sticking	13	13
Difficult to Remove	13	13
Failure to Advance	11	12
Fracture	10	10
Difficult to Insert	10	10
Connection Problem	9	9
Crack	9	9
Therapeutic or Diagnostic Output Failure	8	8
Material Fragmentation	8	8
Tear, Rip or Hole in Device Packaging	8	8
Obstruction of Flow	8	8
Difficult to Advance	7	7
Component Missing	7	7
Insufficient Flow or Under Infusion	7	7
Material Puncture/Hole	6	6
Mechanical Problem	6	6
Device Damaged Prior to Use	6	6
Failure to Deliver	6	6
Use of Device Problem	6	6
Device Dislodged or Dislocated	5	5
Peeled/Delaminated	5	5
Patient Device Interaction Problem	5	5
Product Quality Problem	5	5
Activation, Positioning or Separation Problem	5	5
Difficult to Flush	4	4
Separation Failure	4	4
Unintended Movement	4	4
Entrapment of Device	4	4
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	612	615
No Consequences Or Impact To Patient	152	153
Foreign Body In Patient	66	67
Insufficient Information	65	65
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
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 Blood Pressure/ Hypotension	1	2
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
Muscle/Tendon Damage	1	1
Hyperesthesia	1	1
Dyspnea	1	1
Chest Pain	1	1
Rash	1	1
Spinal Column Injury	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