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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
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
2018 448 448
2019 472 472
2020 274 274
2021 165 165
2022 270 270
2023 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 279 279
Fluid/Blood Leak 245 245
Defective Device 133 133
Leak/Splash 128 128
Detachment of Device or Device Component 82 82
Patient-Device Incompatibility 69 69
Insufficient Information 33 33
No Flow 31 31
Defective Component 30 30
Disconnection 29 29
Output Problem 29 29
Patient Device Interaction Problem 27 27
Difficult to Advance 27 27
Difficult to Remove 26 26
Physical Resistance/Sticking 25 25
Packaging Problem 23 23
Material Separation 23 23
Failure to Advance 23 23
Loose or Intermittent Connection 22 22
Material Fragmentation 22 22
Material Twisted/Bent 22 22
Device Markings/Labelling Problem 22 22
Separation Problem 21 21
Difficult to Insert 21 21
Activation, Positioning or Separation Problem 19 19
Device Contamination with Chemical or Other Material 19 19
Missing Value Reason 18 18
Obstruction of Flow 18 18
Material Split, Cut or Torn 16 16
Infusion or Flow Problem 14 14
Contamination /Decontamination Problem 14 14
Failure to Deliver 14 14
Material Puncture/Hole 13 13
Component Missing 12 12
Tear, Rip or Hole in Device Packaging 11 11
Complete Blockage 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Appropriate Term/Code Not Available 11 11
Therapeutic or Diagnostic Output Failure 10 10
Bent 10 10
Fracture 10 10
Material Too Rigid or Stiff 9 9
Crack 9 9
Material Integrity Problem 9 9
Device Operates Differently Than Expected 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Device Dislodged or Dislocated 8 8
Mechanical Problem 8 8
Device Damaged Prior to Use 7 7
Material Deformation 7 7
Connection Problem 7 7
Positioning Problem 6 6
Insufficient Flow or Under Infusion 6 6
Product Quality Problem 6 6
Use of Device Problem 6 6
Delivered as Unsterile Product 6 6
Difficult to Flush 6 6
Entrapment of Device 5 5
Failure to Infuse 5 5
Unintended Movement 5 5
Deformation Due to Compressive Stress 5 5
Physical Resistance 5 5
Chemical Problem 4 4
Separation Failure 4 4
Volume Accuracy Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Detachment Of Device Component 4 4
Unsealed Device Packaging 3 3
Material Frayed 3 3
Device Slipped 3 3
Blocked Connection 3 3
Device Or Device Fragments Location Unknown 3 3
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Fail-Safe Problem 3 3
Premature Separation 3 3
Difficult to Open or Close 2 2
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Mechanics Altered 2 2
Inadequacy of Device Shape and/or Size 2 2
Dull, Blunt 2 2
Structural Problem 2 2
Unraveled Material 2 2
Peeled/Delaminated 2 2
Misconnection 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Contamination 2 2
Material Disintegration 1 1
Flushing Problem 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1
Coiled 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Occlusion Within Device 1 1
Decrease in Pressure 1 1
Pumping Stopped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 586 586
No Clinical Signs, Symptoms or Conditions 400 400
No Known Impact Or Consequence To Patient 221 221
No Patient Involvement 107 107
Foreign Body In Patient 54 54
No Information 45 45
Pain 42 42
Awareness during Anaesthesia 41 41
Insufficient Information 37 37
Device Embedded In Tissue or Plaque 37 37
Patient Problem/Medical Problem 22 22
Cerebrospinal Fluid Leakage 16 16
Headache 14 14
Numbness 13 13
Headache, Lumbar Puncture 12 12
Infiltration into Tissue 11 11
Inadequate Pain Relief 10 10
Weakness 10 10
Perforation 10 10
Blood Loss 10 10
No Code Available 9 9
Needle Stick/Puncture 7 7
Underdose 5 5
Therapeutic Effects, Unexpected 4 4
Paralysis 3 3
Dyspnea 3 3
Hematoma 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Therapeutic Response, Decreased 2 2
Discomfort 2 2
Injury 1 1
Arachnoiditis, Spinal 1 1
Stenosis 1 1
Paresis 1 1
Tingling 1 1
Sepsis 1 1
Skin Irritation 1 1
Swelling 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Muscle Weakness 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Vascular Problem 1 1
Urethral Stenosis/Stricture 1 1
Ambulation Difficulties 1 1
Low Oxygen Saturation 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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