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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
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
  1.  K190345  VPC
  2.  K202699  E-Cath STIM acc. Tsui

MDR Year MDR Reports MDR Events
2017 353 353
2018 448 448
2019 472 472
2020 273 273
2021 168 168
2022 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Break 341 341
Fluid/Blood Leak 249 249
Defective Device 141 141
Leak/Splash 137 137
Detachment of Device or Device Component 82 82
Patient-Device Incompatibility 61 61
Bent 60 60
Difficult to Advance 55 55
Physical Resistance 39 39
Infusion or Flow Problem 38 38
Insufficient Information 33 33
No Flow 32 32
Disconnection 31 31
Material Fragmentation 30 30
Obstruction of Flow 30 30
Difficult to Remove 29 29
Defective Component 29 29
Output Problem 28 28
Patient Device Interaction Problem 27 27
Device Contamination with Chemical or Other Material 25 25
Difficult to Insert 25 25
Failure to Advance 24 24
Physical Resistance/Sticking 24 24
Activation, Positioning or Separation Problem 23 23
Device Markings/Labelling Problem 23 23
Material Separation 23 23
Loose or Intermittent Connection 22 22
Fracture 21 21
Separation Problem 21 21
Packaging Problem 20 20
Material Twisted/Bent 20 20
Missing Value Reason 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Component Missing 16 16
Failure to Deliver 16 16
Device Operates Differently Than Expected 15 15
Contamination /Decontamination Problem 14 14
Material Split, Cut or Torn 14 14
Appropriate Term/Code Not Available 14 14
Material Puncture/Hole 13 13
Detachment Of Device Component 12 12
Therapeutic or Diagnostic Output Failure 12 12
Crack 11 11
Complete Blockage 10 10
Kinked 10 10
Material Too Rigid or Stiff 10 10
Material Integrity Problem 10 10
Tear, Rip or Hole in Device Packaging 10 10
Device Damaged Prior to Use 9 9
Failure to Infuse 8 8
Mechanical Problem 8 8
Device Dislodged or Dislocated 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Device Handling Problem 8 8
Material Deformation 7 7
Positioning Problem 7 7
Connection Problem 7 7
Difficult to Flush 7 7
Entrapment of Device 7 7
Use of Device Problem 7 7
Product Quality Problem 7 7
Delivered as Unsterile Product 6 6
Improper or Incorrect Procedure or Method 6 6
Insufficient Flow or Under Infusion 6 6
Sticking 5 5
Deformation Due to Compressive Stress 5 5
Device Contaminated During Manufacture or Shipping 5 5
Unintended Movement 5 5
Chemical Problem 4 4
Device Or Device Fragments Location Unknown 4 4
Separation Failure 4 4
Volume Accuracy Problem 4 4
Material Frayed 4 4
Degraded 3 3
Air Leak 3 3
Pumping Stopped 3 3
Unsealed Device Packaging 3 3
Peeled/Delaminated 3 3
Failure to Align 3 3
Blocked Connection 3 3
Fail-Safe Problem 3 3
Premature Separation 3 3
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Mechanics Altered 2 2
Torn Material 2 2
Difficult to Open or Close 2 2
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Improper Flow or Infusion 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Dull, Blunt 2 2
Structural Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Unraveled Material 2 2
Stretched 2 2
Material Perforation 2 2
Microbial Contamination of Device 2 2
Coiled 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 360 360
No Known Impact Or Consequence To Patient 282 282
No Patient Involvement 123 123
Foreign Body In Patient 65 65
No Information 59 59
Device Embedded In Tissue or Plaque 53 53
Pain 53 53
Awareness during Anaesthesia 49 49
Insufficient Information 34 34
Headache, Lumbar Puncture 30 30
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
Bradycardia 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
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 Arrow International Inc II May-30-2018
5 Smiths Medical ASD Inc. II Apr-29-2020
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