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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
Regulation Description 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
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 273 273
2021 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Break 379 379
Fluid Leak 259 259
Leak/Splash 145 145
Defective Device 134 134
Bent 82 82
Difficult to Advance 69 69
Physical Resistance 65 65
Patient-Device Incompatibility 52 52
Detachment of Device or Device Component 51 51
Infusion or Flow Problem 50 50
Difficult to Remove 44 44
Material Fragmentation 39 39
Fracture 35 35
Failure to Advance 34 34
Obstruction of Flow 34 34
Insufficient Information 34 34
Adverse Event Without Identified Device or Use Problem 33 33
Device Contamination with Chemical or Other Material 31 31
Activation, Positioning or SeparationProblem 28 28
Output Problem 27 27
Loose or Intermittent Connection 26 26
Detachment Of Device Component 26 26
Device Operates Differently Than Expected 25 25
No Flow 24 24
Patient Device Interaction Problem 22 22
Kinked 21 21
Crack 21 21
Missing Value Reason 20 20
Difficult to Insert 20 20
Material Separation 20 20
Defective Component 20 20
Device Handling Problem 19 19
Physical Resistance/Sticking 19 19
Disconnection 18 18
Device Markings/Labelling Problem 18 18
Appropriate Term/Code Not Available 18 18
Component Missing 16 16
Material Twisted/Bent 15 15
Failure to Deliver 14 14
Packaging Problem 14 14
Separation Problem 13 13
Material Integrity Problem 13 13
Sticking 12 12
Product Quality Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Puncture/Hole 10 10
Improper or Incorrect Procedure or Method 10 10
Complete Blockage 10 10
Entrapment of Device 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Positioning Problem 9 9
Material Too Rigid or Stiff 9 9
Failure to Infuse 9 9
Material Split, Cut or Torn 9 9
Use of Device Problem 8 8
Device Dislodged or Dislocated 8 8
Contamination /Decontamination Problem 8 8
Tear, Rip or Hole in Device Packaging 8 8
Material Frayed 7 7
Difficult to Flush 7 7
Material Deformation 7 7
Device-Device Incompatibility 7 7
Nonstandard Device 7 7
Device Or Device Fragments Location Unknown 7 7
Hole In Material 6 6
Unraveled Material 6 6
Chemical Problem 6 6
Connection Problem 6 6
Coiled 5 5
Delivered as Unsterile Product 5 5
Deformation Due to Compressive Stress 5 5
Device Contaminated During Manufacture or Shipping 5 5
Partial Blockage 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Insufficient Flow or Under Infusion 5 5
Failure to Align 4 4
Mechanical Problem 4 4
Torn Material 4 4
Unintended Movement 4 4
Unsealed Device Packaging 4 4
Material Protrusion/Extrusion 4 4
Separation Failure 4 4
Occlusion Within Device 4 4
Device Inoperable 4 4
Uncoiled 4 4
Measurement System Incompatibility 3 3
Fail-Safe Problem 3 3
Structural Problem 3 3
Degraded 3 3
Retraction Problem 3 3
Shipping Damage or Problem 3 3
Component Incompatible 3 3
Air Leak 3 3
Peeled/Delaminated 3 3
Cut In Material 3 3
Pumping Stopped 3 3
Stretched 3 3
Device Damaged Prior to Use 3 3
Volume Accuracy Problem 3 3
Premature Separation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 937 937
No Known Impact Or Consequence To Patient 332 332
No Patient Involvement 136 136
No Clinical Signs, Symptoms or Conditions 125 125
No Information 109 109
Awareness during Anaesthesia 93 93
Device Embedded In Tissue or Plaque 75 75
Foreign Body In Patient 62 62
Pain 50 50
Headache, Lumbar Puncture 30 30
Patient Problem/Medical Problem 22 22
No Code Available 21 21
Inadequate Pain Relief 18 18
Cerebrospinal Fluid Leakage 18 18
Not Applicable 17 17
Headache 16 16
Insufficient Information 15 15
Numbness 14 14
Infiltration into Tissue 11 11
Weakness 10 10
Perforation 10 10
Blood Loss 10 10
Needle Stick/Puncture 7 7
Unspecified Infection 5 5
Paralysis 5 5
Underdose 5 5
Therapeutic Effects, Unexpected 4 4
Discomfort 4 4
Therapeutic Response, Decreased 4 4
Dyspnea 3 3
Hematoma 3 3
Tingling 2 2
Skin Irritation 2 2
Arachnoiditis, Spinal 2 2
Incontinence 2 2
Death 2 2
Swelling 2 2
Pregnancy 1 1
Paresis 1 1
Foreign Body Reaction 1 1
Irritability 1 1
Respiratory Distress 1 1
Exposure to Body Fluids 1 1
Burning Sensation 1 1
Stenosis 1 1
Anxiety 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Muscle Weakness 1 1
Sepsis 1 1
Extravasation 1 1
Failure of Implant 1 1
Ambulation Difficulties 1 1
Erythema 1 1
High Blood Pressure/ Hypertension 1 1
Neuropathy 1 1
Wound Dehiscence 1 1
Injury 1 1
Depression 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Neurological Deficit/Dysfunction 1 1
Low Oxygen Saturation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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