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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	135	137
Fluid/Blood Leak	75	75
Leak/Splash	56	56
Detachment of Device or Device Component	56	56
Lack of Effect	41	41
Disconnection	38	38
Material Separation	33	34
Patient-Device Incompatibility	29	29
Defective Component	26	28
Material Twisted/Bent	23	23
Material Split, Cut or Torn	22	22
Complete Blockage	22	22
Adverse Event Without Identified Device or Use Problem	19	20
Packaging Problem	16	16
No Flow	16	16
Loose or Intermittent Connection	14	14
Contamination /Decontamination Problem	13	13
Separation Problem	13	13
Device Markings/Labelling Problem	12	12
Device Contamination with Chemical or Other Material	12	12
Defective Device	12	12
Difficult to Remove	12	12
Fracture	11	11
Difficult to Insert	10	10
Physical Resistance/Sticking	10	10
Crack	8	8
Obstruction of Flow	8	8
Failure to Deliver	7	7
Tear, Rip or Hole in Device Packaging	7	7
Connection Problem	7	7
Therapeutic or Diagnostic Output Failure	7	7
Device Damaged Prior to Use	6	6
Component Missing	6	6
Insufficient Flow or Under Infusion	6	6
Use of Device Problem	6	6
Material Fragmentation	6	6
Mechanical Problem	6	6
Peeled/Delaminated	5	5
Material Deformation	5	5
Patient Device Interaction Problem	5	5
Material Integrity Problem	4	4
Separation Failure	4	4
Unintended Movement	4	4
Material Puncture/Hole	4	4
Product Quality Problem	4	4
Material Frayed	4	4
Entrapment of Device	4	4
Partial Blockage	4	4
Failure to Advance	4	4
Blocked Connection	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	630	633
Insufficient Information	66	66
Foreign Body In Patient	62	63
Pain	13	14
Device Embedded In Tissue or Plaque	8	8
No Consequences Or Impact To Patient	8	8
Awareness during Anaesthesia	7	7
Headache	5	5
Abscess	5	5
Needle Stick/Puncture	5	5
Inadequate Pain Relief	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	5
Unspecified Infection	4	4
Paresthesia	3	3
Chemical Exposure	2	2
Twitching	2	2
Numbness	2	2
No Patient Involvement	2	2
Muscle Weakness	2	2
Bradycardia	2	3
Anxiety	2	2
Failure of Implant	2	2
Foreign Body Reaction	1	1
Spinal Column Injury	1	1
Confusion/ Disorientation	1	1
Rash	1	1
Urethral Stenosis/Stricture	1	1
Chest Pain	1	1
Discomfort	1	1
No Information	1	1
Dyspnea	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
Nausea	1	1
Hyperesthesia	1	1
Muscle/Tendon Damage	1	1
Cerebrospinal Fluid Leakage	1	1
Therapeutic Response, Decreased	1	1
Hypersensitivity/Allergic reaction	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	ICU Medical Inc.	II	Jan-15-2026
2	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024