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	252	252
Fluid/Blood Leak	228	228
Leak/Splash	114	114
Detachment of Device or Device Component	76	76
Patient-Device Incompatibility	70	70
Defective Component	30	30
Disconnection	29	29
No Flow	29	29
Lack of Effect	27	27
Material Separation	27	27
Packaging Problem	25	25
Material Twisted/Bent	24	24
Failure to Advance	24	24
Device Markings/Labelling Problem	21	21
Loose or Intermittent Connection	20	20
Separation Problem	20	20
Activation, Positioning or Separation Problem	19	19
Difficult to Insert	19	19
Difficult to Remove	19	19
Complete Blockage	18	18
Output Problem	17	17
Device Contamination with Chemical or Other Material	17	17
Material Fragmentation	15	15
Physical Resistance/Sticking	15	15
Defective Device	14	14
Material Split, Cut or Torn	14	14
Contamination /Decontamination Problem	13	13
Obstruction of Flow	13	13
Tear, Rip or Hole in Device Packaging	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Difficult to Advance	11	11
Therapeutic or Diagnostic Output Failure	11	11
Material Puncture/Hole	10	10
Infusion or Flow Problem	10	10
Component Missing	10	10
Material Too Rigid or Stiff	9	9
Connection Problem	8	8
Mechanical Problem	7	7
Device Dislodged or Dislocated	7	7
Device Damaged Prior to Use	6	6
Crack	6	6
Fracture	6	6
Delivered as Unsterile Product	6	6
Appropriate Term/Code Not Available	6	6
Insufficient Flow or Under Infusion	6	6
Difficult to Flush	5	5
Unintended Movement	5	5
Insufficient Information	5	5
Product Quality Problem	5	5
Patient Device Interaction Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	473	473
No Consequences Or Impact To Patient	338	338
No Known Impact Or Consequence To Patient	141	141
No Patient Involvement	106	106
Foreign Body In Patient	53	53
Insufficient Information	52	52
No Information	35	35
Pain	28	28
Device Embedded In Tissue or Plaque	23	23
Awareness during Anaesthesia	21	21
Cerebrospinal Fluid Leakage	16	16
Inadequate Pain Relief	11	11
Infiltration into Tissue	11	11
Perforation	10	10
Headache, Lumbar Puncture	10	10
Blood Loss	10	10
Headache	7	7
Needle Stick/Puncture	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Therapeutic Effects, Unexpected	4	4
Dyspnea	4	4
No Code Available	3	3
Discomfort	3	3
Numbness	3	3
Underdose	2	2
Therapeutic Response, Decreased	2	2
Anxiety	2	2
Bradycardia	2	2
Twitching	2	2
Failure of Implant	2	2
Patient Problem/Medical Problem	2	2
Unspecified Infection	2	2
Chest Pain	1	1
Exposure to Body Fluids	1	1
Injury	1	1
Hyperesthesia	1	1
Confusion/ Disorientation	1	1
Extravasation	1	1
Undesired Nerve Stimulation	1	1
Foreign Body Reaction	1	1
Urethral Stenosis/Stricture	1	1
Nausea	1	1
Tingling	1	1
Neuropathy	1	1
High Blood Pressure/ Hypertension	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Urinary Tract Infection	1	1