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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
2019 472 472
2020 274 274
2021 165 165
2022 270 270
2023 60 60
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 244 244
Fluid/Blood Leak 226 226
Leak/Splash 108 108
Detachment of Device or Device Component 76 76
Patient-Device Incompatibility 70 70
Defective Component 29 29
No Flow 29 29
Disconnection 24 24
Failure to Advance 23 23
Packaging Problem 23 23
Material Twisted/Bent 22 22
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
Device Contamination with Chemical or Other Material 17 17
Output Problem 17 17
Physical Resistance/Sticking 15 15
Material Fragmentation 15 15
Complete Blockage 15 15
Defective Device 14 14
Obstruction of Flow 13 13
Material Split, Cut or Torn 13 13
Contamination /Decontamination Problem 12 12
Difficult to Advance 11 11
Tear, Rip or Hole in Device Packaging 11 11
Component Missing 10 10
Material Puncture/Hole 10 10
Therapeutic or Diagnostic Output Failure 10 10
Infusion or Flow Problem 10 10
Material Too Rigid or Stiff 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Lack of Effect 8 8
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
Connection Problem 5 5
Use of Device Problem 5 5
Insufficient Flow or Under Infusion 5 5
Volume Accuracy Problem 4 4
Separation Failure 4 4
Entrapment of Device 4 4
Material Deformation 4 4
Material Integrity Problem 4 4
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Blocked Connection 3 3
Chemical Problem 3 3
Fail-Safe Problem 3 3
Failure to Deliver 3 3
Failure to Infuse 2 2
Device Slipped 2 2
Unraveled Material 2 2
Structural Problem 2 2
Gas/Air Leak 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
Improper Chemical Reaction 2 2
Mechanics Altered 2 2
Positioning Problem 2 2
Premature Separation 2 2
Insufficient Information 2 2
Illegible Information 1 1
Priming Problem 1 1
Activation Problem 1 1
Failure to Eject 1 1
Pressure Problem 1 1
No Apparent Adverse Event 1 1
Improper Flow or Infusion 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
Human-Device Interface Problem 1 1
Difficult to Open or Close 1 1
Device Damaged by Another Device 1 1
Deformation Due to Compressive Stress 1 1
Expiration Date Error 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 420 420
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 48 48
Insufficient Information 40 40
No Information 35 35
Pain 25 25
Device Embedded In Tissue or Plaque 21 21
Awareness during Anaesthesia 21 21
Cerebrospinal Fluid Leakage 15 15
Inadequate Pain Relief 11 11
Infiltration into Tissue 11 11
Headache, Lumbar Puncture 10 10
Perforation 10 10
Blood Loss 10 10
Headache 7 7
Needle Stick/Puncture 5 5
Therapeutic Effects, Unexpected 4 4
No Code Available 3 3
Discomfort 3 3
Numbness 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Dyspnea 3 3
Therapeutic Response, Decreased 2 2
Patient Problem/Medical Problem 2 2
Unspecified Infection 2 2
Failure of Implant 2 2
Underdose 2 2
Anxiety 2 2
Exposure to Body Fluids 1 1
Extravasation 1 1
Bradycardia 1 1
Foreign Body Reaction 1 1
Injury 1 1
Urethral Stenosis/Stricture 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Unspecified Vascular Problem 1 1
High Blood Pressure/ Hypertension 1 1
Tingling 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 Smiths Medical ASD Inc. II Apr-29-2020
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