TPLC - Total Product Life Cycle

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Device	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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	358	358
Fluid/Blood Leak	252	252
Leak/Splash	154	154
Defective Device	142	142
Detachment of Device or Device Component	83	83
Patient-Device Incompatibility	70	70
Bent	60	60
Difficult to Advance	56	56
Infusion or Flow Problem	39	39
Physical Resistance	39	39
Defective Component	37	37
Insufficient Information	36	36
Disconnection	36	36
Material Separation	32	32
No Flow	32	32
Material Fragmentation	31	31
Obstruction of Flow	31	31
Difficult to Remove	30	30
Device Contamination with Chemical or Other Material	29	29
Output Problem	29	29
Patient Device Interaction Problem	27	27
Lack of Effect	27	27
Failure to Advance	26	26
Material Twisted/Bent	26	26
Packaging Problem	26	26
Physical Resistance/Sticking	25	25
Difficult to Insert	25	25
Device Markings/Labelling Problem	24	24
Activation, Positioning or Separation Problem	23	23
Loose or Intermittent Connection	23	23
Adverse Event Without Identified Device or Use Problem	21	21
Separation Problem	21	21
Fracture	21	21
Complete Blockage	19	19
Material Split, Cut or Torn	18	18
Missing Value Reason	18	18
Failure to Deliver	16	16
Component Missing	16	16
Device Operates Differently Than Expected	15	15
Contamination /Decontamination Problem	15	15
Appropriate Term/Code Not Available	14	14
Crack	14	14
Tear, Rip or Hole in Device Packaging	13	13
Material Puncture/Hole	13	13
Therapeutic or Diagnostic Output Failure	13	13
Detachment Of Device Component	12	12
Material Too Rigid or Stiff	10	10
Material Integrity Problem	10	10
Connection Problem	10	10
Kinked	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	770	770
No Clinical Signs, Symptoms or Conditions	474	474
No Known Impact Or Consequence To Patient	282	282
No Patient Involvement	124	124
Foreign Body In Patient	77	77
No Information	59	59
Pain	56	56
Device Embedded In Tissue or Plaque	56	56
Insufficient Information	52	52
Awareness during Anaesthesia	49	49
Headache, Lumbar Puncture	30	30
Patient Problem/Medical Problem	22	22
Cerebrospinal Fluid Leakage	17	17
Inadequate Pain Relief	14	14
Headache	14	14
Numbness	13	13
No Code Available	13	13
Infiltration into Tissue	11	11
Weakness	10	10
Blood Loss	10	10
Perforation	10	10
Needle Stick/Puncture	8	8
Underdose	5	5
Unspecified Infection	5	5
Therapeutic Effects, Unexpected	4	4
Paralysis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Dyspnea	4	4
Hematoma	3	3
Not Applicable	3	3
Discomfort	3	3
Anxiety	3	3
Arachnoiditis, Spinal	2	2
Low Blood Pressure/ Hypotension	2	2
Failure of Implant	2	2
Death	2	2
Therapeutic Response, Decreased	2	2
Tingling	2	2
Twitching	2	2
Bradycardia	2	2
Unspecified Vascular Problem	1	1
Loss of consciousness	1	1
Low Oxygen Saturation	1	1
Ambulation Difficulties	1	1
Undesired Nerve Stimulation	1	1
Urinary Tract Infection	1	1
Extravasation	1	1
Stenosis	1	1
Hyperesthesia	1	1
Paresis	1	1