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U.S. Department of Health and Human Services

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 CodeCAZ
Regulation Number 868.5140
Device Class 2


Premarket Reviews
ManufacturerDecision
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 353 353
2018 448 448
2019 472 472
2020 273 273
2021 168 168
2022 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 308 308
Fluid Leak 241 241
Defective Device 133 133
Leak/Splash 124 124
Bent 60 60
Patient-Device Incompatibility 57 57
Difficult to Advance 53 53
Detachment of Device or Device Component 47 47
Physical Resistance 39 39
Infusion or Flow Problem 38 38
Insufficient Information 33 33
Material Fragmentation 30 30
Obstruction of Flow 29 29
Output Problem 28 28
No Flow 26 26
Difficult to Remove 26 26
Failure to Advance 24 24
Device Contamination with Chemical or Other Material 23 23
Activation, Positioning or SeparationProblem 23 23
Patient Device Interaction Problem 22 22
Physical Resistance/Sticking 20 20
Device Markings/Labelling Problem 20 20
Defective Component 20 20
Disconnection 18 18
Missing Value Reason 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Fracture 17 17
Difficult to Insert 17 17
Loose or Intermittent Connection 16 16
Material Separation 16 16
Material Twisted/Bent 16 16
Packaging Problem 16 16
Device Operates Differently Than Expected 15 15
Appropriate Term/Code Not Available 14 14
Failure to Deliver 14 14
Separation Problem 13 13
Component Missing 13 13
Material Split, Cut or Torn 12 12
Detachment Of Device Component 12 12
Crack 11 11
Therapeutic or Diagnostic Output Failure 11 11
Contamination /Decontamination Problem 11 11
Material Integrity Problem 10 10
Kinked 10 10
Material Puncture/Hole 10 10
Material Too Rigid or Stiff 8 8
Failure to Infuse 8 8
Tear, Rip or Hole in Device Packaging 8 8
Complete Blockage 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Device Handling Problem 8 8
Positioning Problem 7 7
Device Dislodged or Dislocated 7 7
Difficult to Flush 7 7
Use of Device Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Material Deformation 6 6
Device Contaminated During Manufacture or Shipping 5 5
Deformation Due to Compressive Stress 5 5
Insufficient Flow or Under Infusion 5 5
Sticking 5 5
Entrapment of Device 5 5
Delivered as Unsterile Product 5 5
Mechanical Problem 4 4
Material Frayed 4 4
Volume Accuracy Problem 4 4
Product Quality Problem 4 4
Chemical Problem 4 4
Connection Problem 4 4
Device Or Device Fragments Location Unknown 4 4
Separation Failure 4 4
Failure to Align 3 3
Device Damaged Prior to Use 3 3
Fail-Safe Problem 3 3
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Unintended Movement 3 3
Premature Separation 3 3
Pumping Stopped 3 3
Unsealed Device Packaging 3 3
Peeled/Delaminated 3 3
Degraded 3 3
Air Leak 3 3
Coiled 2 2
Burst Container or Vessel 2 2
Hole In Material 2 2
Misconnection 2 2
Nonstandard Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Stretched 2 2
Microbial Contamination of Device 2 2
Unraveled Material 2 2
Material Perforation 2 2
Torn Material 2 2
Mechanics Altered 2 2
Improper Flow or Infusion 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Structural Problem 2 2
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 770 770
No Known Impact Or Consequence To Patient 282 282
No Clinical Signs, Symptoms or Conditions 157 157
No Patient Involvement 123 123
Foreign Body In Patient 60 60
No Information 59 59
Device Embedded In Tissue or Plaque 51 51
Awareness during Anaesthesia 48 48
Pain 46 46
Headache, Lumbar Puncture 30 30
Insufficient Information 25 25
Patient Problem/Medical Problem 22 22
Cerebrospinal Fluid Leakage 16 16
Headache 14 14
Inadequate Pain Relief 13 13
Numbness 13 13
No Code Available 13 13
Infiltration into Tissue 11 11
Weakness 10 10
Perforation 10 10
Blood Loss 10 10
Needle Stick/Puncture 6 6
Underdose 5 5
Unspecified Infection 5 5
Paralysis 4 4
Therapeutic Effects, Unexpected 4 4
Dyspnea 3 3
Hematoma 3 3
Not Applicable 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Arachnoiditis, Spinal 2 2
Death 2 2
Failure of Implant 2 2
Therapeutic Response, Decreased 2 2
Discomfort 2 2
Tingling 2 2
Paresis 1 1
Sepsis 1 1
Skin Irritation 1 1
Swelling 1 1
Injury 1 1
Depression 1 1
Anxiety 1 1
Stenosis 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Muscle Weakness 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Exposure to Body Fluids 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1
Ambulation Difficulties 1 1
Pregnancy 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 Arrow International Inc II May-30-2018
5 Smiths Medical ASD Inc. II Apr-29-2020
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