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	126	128
Fluid/Blood Leak	78	78
Detachment of Device or Device Component	55	55
Leak/Splash	51	51
Lack of Effect	41	41
Disconnection	40	40
Patient-Device Incompatibility	29	29
Material Separation	29	30
Defective Component	25	27
Material Twisted/Bent	24	24
Adverse Event Without Identified Device or Use Problem	23	24
Material Split, Cut or Torn	23	23
Complete Blockage	21	21
No Flow	17	17
Packaging Problem	15	15
Loose or Intermittent Connection	13	13
Separation Problem	13	13
Device Markings/Labelling Problem	12	12
Device Contamination with Chemical or Other Material	12	12
Fracture	11	11
Defective Device	10	10
Difficult to Remove	10	10
Contamination /Decontamination Problem	10	10
Difficult to Insert	10	10
Obstruction of Flow	10	10
Crack	9	9
Connection Problem	8	8
Tear, Rip or Hole in Device Packaging	7	7
Failure to Deliver	7	7
Device Damaged Prior to Use	6	6
Use of Device Problem	6	6
Peeled/Delaminated	5	5
Physical Resistance/Sticking	5	5
Mechanical Problem	5	5
Material Deformation	5	5
Therapeutic or Diagnostic Output Failure	5	5
Insufficient Flow or Under Infusion	5	5
Patient Device Interaction Problem	5	5
Material Fragmentation	5	5
Component Missing	5	5
Product Quality Problem	4	4
Partial Blockage	4	4
Separation Failure	4	4
Material Rupture	4	4
Unintended Movement	4	4
Failure to Advance	3	3
Unexpected Therapeutic Results	3	3
Infusion or Flow Problem	3	3
Blocked Connection	3	3
Insufficient Device Problem Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	649	652
Foreign Body In Patient	71	72
Insufficient Information	68	68
Pain	14	15
Device Embedded In Tissue or Plaque	8	8
No Consequences Or Impact To Patient	8	8
Awareness during Anaesthesia	8	8
Inadequate Pain Relief	6	6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	6
Headache	5	5
Abscess	5	5
Needle Stick/Puncture	5	5
Unspecified Infection	4	4
Numbness	4	4
Paresthesia	3	3
Respiratory Insufficiency	2	2
Anxiety	2	2
Bradycardia	2	3
No Patient Involvement	2	2
Discomfort	2	2
Twitching	2	2
Chemical Exposure	2	2
Failure of Implant	2	2
Skin Infection	2	2
Muscle Weakness/Atrophy	2	2
Chest Pain	1	1
Rash	1	1
Dural Tear	1	1
Confusion/ Disorientation	1	1
Dyspnea	1	1
Spinal Column Injury	1	1
Foreign Body Reaction	1	1
Urethral Stenosis/Stricture	1	1
Hyperesthesia	1	1
Muscle/Tendon Damage	1	1
Cerebrospinal Fluid Leakage	1	1
Therapeutic Response, Decreased	1	1
No Information	1	1
Nausea	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Hypersensitivity/Allergic reaction	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, LLC	I	Jun-13-2026
2	B Braun Medical Inc	II	May-29-2026
3	Becton Dickinson & Company	I	May-29-2026
4	ICU Medical Inc.	II	Jan-15-2026
5	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024