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
Fluid/Blood Leak	137	137
Break	133	133
Leak/Splash	85	85
Patient-Device Incompatibility	56	56
Detachment of Device or Device Component	55	55
Lack of Effect	37	37
Disconnection	31	31
Material Separation	26	26
Defective Component	24	24
No Flow	22	22
Material Twisted/Bent	22	22
Packaging Problem	21	21
Complete Blockage	20	20
Material Split, Cut or Torn	15	15
Device Contamination with Chemical or Other Material	13	13
Contamination /Decontamination Problem	13	13
Defective Device	13	13
Adverse Event Without Identified Device or Use Problem	13	13
Device Markings/Labelling Problem	13	13
Difficult to Remove	12	12
Separation Problem	12	12
Loose or Intermittent Connection	12	12
Failure to Advance	11	11
Difficult to Insert	10	10
Physical Resistance/Sticking	10	10
Connection Problem	9	9
Material Fragmentation	8	8
Fracture	8	8
Obstruction of Flow	7	7
Tear, Rip or Hole in Device Packaging	7	7
Difficult to Advance	7	7
Therapeutic or Diagnostic Output Failure	7	7
Component Missing	7	7
Insufficient Flow or Under Infusion	6	6
Mechanical Problem	6	6
Device Damaged Prior to Use	6	6
Crack	6	6
Use of Device Problem	6	6
Material Puncture/Hole	6	6
Patient Device Interaction Problem	5	5
Device Dislodged or Dislocated	5	5
Product Quality Problem	5	5
Activation, Positioning or Separation Problem	5	5
Failure to Deliver	5	5
Separation Failure	4	4
Volume Accuracy Problem	4	4
Unintended Movement	4	4
Blocked Connection	4	4
Material Deformation	4	4
Difficult to Flush	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	530	530
No Consequences Or Impact To Patient	152	152
Insufficient Information	59	59
Foreign Body In Patient	47	47
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
Chemical Exposure	2	2
Failure of Implant	2	2
Bradycardia	2	2
Anxiety	2	2
Twitching	2	2
Muscle Weakness	2	2
Nicks, cuts or tears of dura or other tissues by device	1	1
Confusion/ Disorientation	1	1
Underdose	1	1
Cerebrospinal Fluid Leakage	1	1
Chest Pain	1	1
Dyspnea	1	1
Foreign Body Reaction	1	1
Low Oxygen Saturation	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Loss of consciousness	1	1
Therapeutic Response, Decreased	1	1
Urinary Tract Infection	1	1
Therapeutic Effects, Unexpected	1	1
Rash	1	1
Nervous System Injury	1	1
Undesired Nerve Stimulation	1	1
Nausea	1	1
No Code Available	1	1
Hyperesthesia	1	1
Unspecified Vascular Problem	1	1
Urethral Stenosis/Stricture	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