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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
2019 472 472
2020 274 274
2021 165 165
2022 270 270
2023 60 60
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Break 245 245
Fluid/Blood Leak 226 226
Leak/Splash 108 108
Detachment of Device or Device Component 76 76
Patient-Device Incompatibility 70 70
Defective Component 30 30
No Flow 29 29
Disconnection 25 25
Failure to Advance 23 23
Material Twisted/Bent 23 23
Packaging Problem 23 23
Material Separation 22 22
Loose or Intermittent Connection 20 20
Device Markings/Labelling Problem 20 20
Separation Problem 20 20
Activation, Positioning or Separation Problem 19 19
Difficult to Remove 19 19
Difficult to Insert 19 19
Output Problem 17 17
Device Contamination with Chemical or Other Material 17 17
Complete Blockage 16 16
Material Fragmentation 15 15
Physical Resistance/Sticking 15 15
Material Split, Cut or Torn 14 14
Lack of Effect 14 14
Defective Device 14 14
Obstruction of Flow 13 13
Contamination /Decontamination Problem 12 12
Difficult to Advance 11 11
Tear, Rip or Hole in Device Packaging 11 11
Therapeutic or Diagnostic Output Failure 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Infusion or Flow Problem 10 10
Component Missing 10 10
Material Puncture/Hole 10 10
Material Too Rigid or Stiff 9 9
Mechanical Problem 7 7
Device Dislodged or Dislocated 7 7
Device Damaged Prior to Use 6 6
Delivered as Unsterile Product 6 6
Fracture 6 6
Appropriate Term/Code Not Available 6 6
Patient Device Interaction Problem 5 5
Unintended Movement 5 5
Product Quality Problem 5 5
Difficult to Flush 5 5
Crack 5 5
Insufficient Flow or Under Infusion 5 5
Use of Device Problem 5 5
Connection Problem 5 5
Separation Failure 4 4
Volume Accuracy Problem 4 4
Entrapment of Device 4 4
Material Deformation 4 4
Material Integrity Problem 4 4
Material Protrusion/Extrusion 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Measurement System Incompatibility 3 3
Compatibility Problem 3 3
Insufficient Information 3 3
Failure to Deliver 3 3
Blocked Connection 3 3
Fail-Safe Problem 3 3
Chemical Problem 3 3
Failure to Infuse 2 2
Dull, Blunt 2 2
Structural Problem 2 2
Device Slipped 2 2
Unraveled Material 2 2
Material Frayed 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Misconnection 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 2 2
Premature Separation 2 2
Positioning Problem 2 2
Mechanics Altered 2 2
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Improper Flow or Infusion 1 1
Human-Device Interface Problem 1 1
Pressure Problem 1 1
Illegible Information 1 1
No Apparent Adverse Event 1 1
Failure to Eject 1 1
Priming Problem 1 1
Activation Problem 1 1
Pumping Stopped 1 1
Misassembled 1 1
Inadequacy of Device Shape and/or Size 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1
Contamination 1 1
Material Disintegration 1 1
Labelling, Instructions for Use or Training Problem 1 1
Flushing Problem 1 1
Fitting Problem 1 1
Material Perforation 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 435 435
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 50 50
Insufficient Information 41 41
No Information 35 35
Pain 27 27
Awareness during Anaesthesia 21 21
Device Embedded In Tissue or Plaque 21 21
Cerebrospinal Fluid Leakage 15 15
Infiltration into Tissue 11 11
Inadequate Pain Relief 11 11
Headache, Lumbar Puncture 10 10
Perforation 10 10
Blood Loss 10 10
Headache 7 7
Needle Stick/Puncture 5 5
Dyspnea 4 4
Therapeutic Effects, Unexpected 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Numbness 3 3
Discomfort 3 3
Therapeutic Response, Decreased 2 2
Anxiety 2 2
Bradycardia 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Patient Problem/Medical Problem 2 2
Underdose 2 2
Confusion/ Disorientation 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Injury 1 1
Urinary Tract Infection 1 1
Tingling 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Chest Pain 1 1
Exposure to Body Fluids 1 1
Hyperesthesia 1 1
Unspecified Vascular Problem 1 1
Urethral Stenosis/Stricture 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 Smiths Medical ASD Inc. II Apr-29-2020
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