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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
TELEFLEX INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 372 372
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 435 435
Fluid/Blood Leak 270 270
Leak/Splash 169 169
Defective Device 143 143
Detachment of Device or Device Component 88 88
Bent 82 82
Patient-Device Incompatibility 72 72
Difficult to Advance 72 72
Physical Resistance 65 65
Difficult to Remove 52 52
Infusion or Flow Problem 51 51
Material Fragmentation 40 40
Fracture 39 39
Device Contamination with Chemical or Other Material 39 39
Obstruction of Flow 38 38
Defective Component 37 37
Adverse Event Without Identified Device or Use Problem 36 36
Failure to Advance 35 35
Disconnection 34 34
Insufficient Information 34 34
Loose or Intermittent Connection 33 33
Material Separation 33 33
No Flow 33 33
Output Problem 29 29
Activation, Positioning or Separation Problem 28 28
Difficult to Insert 28 28
Patient Device Interaction Problem 27 27
Detachment Of Device Component 26 26
Device Operates Differently Than Expected 25 25
Packaging Problem 25 25
Material Twisted/Bent 25 25
Physical Resistance/Sticking 25 25
Device Markings/Labelling Problem 23 23
Crack 23 23
Kinked 21 21
Separation Problem 21 21
Missing Value Reason 20 20
Component Missing 20 20
Complete Blockage 19 19
Device Handling Problem 19 19
Material Split, Cut or Torn 18 18
Appropriate Term/Code Not Available 18 18
Failure to Deliver 16 16
Product Quality Problem 15 15
Contamination /Decontamination Problem 14 14
Material Integrity Problem 14 14
Therapeutic or Diagnostic Output Failure 14 14
Lack of Effect 13 13
Tear, Rip or Hole in Device Packaging 13 13
Material Puncture/Hole 13 13
Sticking 12 12
Entrapment of Device 12 12
Improper or Incorrect Procedure or Method 11 11
Material Too Rigid or Stiff 11 11
Mechanical Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Device Dislodged or Dislocated 10 10
Material Deformation 9 9
Failure to Infuse 9 9
Connection Problem 9 9
Device Damaged Prior to Use 9 9
Positioning Problem 9 9
Use of Device Problem 8 8
Difficult to Flush 8 8
Material Frayed 7 7
Nonstandard Device 7 7
Device Or Device Fragments Location Unknown 7 7
Device-Device Incompatibility 7 7
Chemical Problem 6 6
Delivered as Unsterile Product 6 6
Unraveled Material 6 6
Insufficient Flow or Under Infusion 6 6
Hole In Material 6 6
Unintended Movement 6 6
Coiled 5 5
Partial Blockage 5 5
Unsealed Device Packaging 5 5
Deformation Due to Compressive Stress 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Protrusion/Extrusion 4 4
Failure to Align 4 4
Separation Failure 4 4
Occlusion Within Device 4 4
Volume Accuracy Problem 4 4
Uncoiled 4 4
Device Inoperable 4 4
Torn Material 4 4
Premature Separation 3 3
Stretched 3 3
Device Slipped 3 3
Peeled/Delaminated 3 3
Shipping Damage or Problem 3 3
Retraction Problem 3 3
Air Leak 3 3
Degraded 3 3
Component Incompatible 3 3
Cut In Material 3 3
Structural Problem 3 3
Dull, Blunt 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 937 937
No Clinical Signs, Symptoms or Conditions 430 430
No Known Impact Or Consequence To Patient 332 332
No Patient Involvement 137 137
No Information 109 109
Awareness during Anaesthesia 94 94
Foreign Body In Patient 83 83
Device Embedded In Tissue or Plaque 78 78
Pain 60 60
Insufficient Information 42 42
Headache, Lumbar Puncture 30 30
Patient Problem/Medical Problem 22 22
No Code Available 21 21
Inadequate Pain Relief 19 19
Cerebrospinal Fluid Leakage 18 18
Not Applicable 17 17
Headache 16 16
Numbness 14 14
Infiltration into Tissue 11 11
Perforation 10 10
Weakness 10 10
Blood Loss 10 10
Needle Stick/Puncture 8 8
Discomfort 5 5
Underdose 5 5
Paralysis 5 5
Unspecified Infection 5 5
Therapeutic Effects, Unexpected 4 4
Dyspnea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Therapeutic Response, Decreased 4 4
Anxiety 3 3
Hematoma 3 3
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 2 2
Incontinence 2 2
Bradycardia 2 2
Skin Irritation 2 2
Swelling 2 2
Death 2 2
Tingling 2 2
Arachnoiditis, Spinal 2 2
Reaction 1 1
Low Oxygen Saturation 1 1
Loss of consciousness 1 1
Irritability 1 1
Post Operative Wound Infection 1 1
Stenosis 1 1
Injury 1 1
Depression 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
Paresis 1 1
Muscle Weakness 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Respiratory Distress 1 1
Sepsis 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Wound Dehiscence 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Chest Pain 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 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 Becton Dickinson & Company II Nov-10-2016
6 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Sep-21-2016
7 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Aug-29-2016
8 Smiths Medical ASD Inc. II Apr-29-2020
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