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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
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

MDR Year MDR Reports MDR Events
2017 353 353
2018 448 448
2019 472 472
2020 274 274
2021 165 165
2022 270 270
2023 60 60
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Break 351 351
Fluid/Blood Leak 250 250
Leak/Splash 148 148
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
Physical Resistance 39 39
Infusion or Flow Problem 39 39
Defective Component 37 37
Insufficient Information 33 33
Disconnection 32 32
No Flow 32 32
Obstruction of Flow 31 31
Material Fragmentation 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
Material Separation 27 27
Physical Resistance/Sticking 25 25
Difficult to Insert 25 25
Failure to Advance 25 25
Material Twisted/Bent 24 24
Packaging Problem 24 24
Loose or Intermittent Connection 23 23
Device Markings/Labelling Problem 23 23
Activation, Positioning or Separation Problem 23 23
Fracture 21 21
Separation Problem 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Material Split, Cut or Torn 18 18
Missing Value Reason 18 18
Complete Blockage 17 17
Component Missing 16 16
Failure to Deliver 16 16
Device Operates Differently Than Expected 15 15
Appropriate Term/Code Not Available 14 14
Contamination /Decontamination Problem 14 14
Lack of Effect 13 13
Material Puncture/Hole 13 13
Therapeutic or Diagnostic Output Failure 13 13
Crack 13 13
Detachment Of Device Component 12 12
Tear, Rip or Hole in Device Packaging 12 12
Material Integrity Problem 10 10
Material Too Rigid or Stiff 10 10
Kinked 10 10
Device Damaged Prior to Use 9 9
Mechanical Problem 9 9
Device Dislodged or Dislocated 9 9
Difficult to Flush 8 8
Product Quality Problem 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Device Handling Problem 8 8
Material Deformation 8 8
Failure to Infuse 8 8
Entrapment of Device 7 7
Positioning Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Use of Device Problem 7 7
Connection Problem 7 7
Delivered as Unsterile Product 6 6
Insufficient Flow or Under Infusion 6 6
Sticking 5 5
Device Contaminated During Manufacture or Shipping 5 5
Unintended Movement 5 5
Deformation Due to Compressive Stress 5 5
Material Frayed 4 4
Chemical Problem 4 4
Separation Failure 4 4
Unsealed Device Packaging 4 4
Volume Accuracy Problem 4 4
Device Or Device Fragments Location Unknown 4 4
Blocked Connection 3 3
Failure to Align 3 3
Device Slipped 3 3
Premature Separation 3 3
Dull, Blunt 3 3
Air Leak 3 3
Material Protrusion/Extrusion 3 3
Peeled/Delaminated 3 3
Fail-Safe Problem 3 3
Degraded 3 3
Measurement System Incompatibility 3 3
Burst Container or Vessel 2 2
Gas/Air Leak 2 2
Contamination 2 2
Misconnection 2 2
Difficult to Open or Close 2 2
Structural Problem 2 2
Coiled 2 2
Unraveled Material 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Inadequacy of Device Shape and/or Size 2 2
Hole In Material 2 2
Mechanics Altered 2 2
Improper Chemical Reaction 2 2
Device Alarm System 2 2

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 430 430
No Known Impact Or Consequence To Patient 282 282
No Patient Involvement 124 124
Foreign Body In Patient 73 73
No Information 59 59
Pain 55 55
Device Embedded In Tissue or Plaque 54 54
Awareness during Anaesthesia 49 49
Insufficient Information 41 41
Headache, Lumbar Puncture 30 30
Patient Problem/Medical Problem 22 22
Cerebrospinal Fluid Leakage 16 16
Headache 14 14
Inadequate Pain Relief 14 14
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 7 7
Underdose 5 5
Unspecified Infection 5 5
Paralysis 4 4
Therapeutic Effects, Unexpected 4 4
Dyspnea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Not Applicable 3 3
Hematoma 3 3
Anxiety 3 3
Discomfort 3 3
Tingling 2 2
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 2 2
Bradycardia 2 2
Death 2 2
Therapeutic Response, Decreased 2 2
Arachnoiditis, Spinal 2 2
Stenosis 1 1
Low Oxygen Saturation 1 1
Loss of consciousness 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Pregnancy 1 1
Hyperesthesia 1 1
Unspecified Vascular Problem 1 1
Urethral Stenosis/Stricture 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Chest Pain 1 1
Exposure to Body Fluids 1 1
High Blood Pressure/ Hypertension 1 1
Muscle Weakness 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Injury 1 1
Depression 1 1
Urinary Tract Infection 1 1
Paresis 1 1
Sepsis 1 1
Skin Irritation 1 1
Swelling 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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