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	168	168
Fluid/Blood Leak	152	152
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	31
Defective Component	27	27
Material Twisted/Bent	26	26
Adverse Event Without Identified Device or Use Problem	24	24
Material Split, Cut or Torn	24	24
Complete Blockage	22	22
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	11
Fracture	10	10
Difficult to Insert	10	10
Connection Problem	9	9
Crack	9	9
Tear, Rip or Hole in Device Packaging	8	8
Material Fragmentation	8	8
Therapeutic or Diagnostic Output Failure	8	8
Difficult to Advance	7	7
Insufficient Flow or Under Infusion	7	7
Component Missing	7	7
Obstruction of Flow	7	7
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Failure to Deliver	6	6
Device Damaged Prior to Use	6	6
Use of Device Problem	6	6
Device Dislodged or Dislocated	5	5
Product Quality Problem	5	5
Peeled/Delaminated	5	5
Patient Device Interaction Problem	5	5
Activation, Positioning or Separation Problem	5	5
Unintended Movement	4	4
Entrapment of Device	4	4
Volume Accuracy Problem	4	4
Material Integrity Problem	4	4
Separation Failure	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	607	607
No Consequences Or Impact To Patient	152	152
Insufficient Information	64	64
Foreign Body In Patient	63	63
No Known Impact Or Consequence To Patient	34	34
Awareness during Anaesthesia	26	26
No Patient Involvement	21	21
Pain	20	20
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	2
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	1
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	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
5	Smiths Medical ASD Inc.	II	Apr-29-2020