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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

MDR Year MDR Reports MDR Events
2017 353 353
2018 448 448
2019 472 472
2020 273 273
2021 168 168
2022 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Break 332 332
Fluid Leak 246 246
Defective Device 134 134
Leak/Splash 131 131
Bent 60 60
Patient-Device Incompatibility 60 60
Difficult to Advance 55 55
Detachment of Device or Device Component 54 54
Physical Resistance 39 39
Infusion or Flow Problem 38 38
Insufficient Information 33 33
Obstruction of Flow 30 30
Material Fragmentation 30 30
Difficult to Remove 29 29
No Flow 28 28
Output Problem 28 28
Defective Component 26 26
Disconnection 25 25
Failure to Advance 24 24
Device Contamination with Chemical or Other Material 24 24
Patient Device Interaction Problem 23 23
Physical Resistance/Sticking 23 23
Activation, Positioning or SeparationProblem 23 23
Material Separation 23 23
Difficult to Insert 22 22
Device Markings/Labelling Problem 21 21
Loose or Intermittent Connection 20 20
Separation Problem 18 18
Missing Value Reason 18 18
Material Twisted/Bent 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Fracture 17 17
Packaging Problem 16 16
Device Operates Differently Than Expected 15 15
Appropriate Term/Code Not Available 14 14
Failure to Deliver 14 14
Material Split, Cut or Torn 13 13
Component Missing 13 13
Material Puncture/Hole 12 12
Detachment Of Device Component 12 12
Crack 11 11
Contamination /Decontamination Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Integrity Problem 10 10
Kinked 10 10
Complete Blockage 9 9
Material Too Rigid or Stiff 9 9
Tear, Rip or Hole in Device Packaging 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Device Handling Problem 8 8
Failure to Infuse 8 8
Device Damaged Prior to Use 7 7
Use of Device Problem 7 7
Entrapment of Device 7 7
Difficult to Flush 7 7
Positioning Problem 7 7
Connection Problem 7 7
Device Dislodged or Dislocated 7 7
Material Deformation 6 6
Improper or Incorrect Procedure or Method 6 6
Insufficient Flow or Under Infusion 6 6
Sticking 5 5
Delivered as Unsterile Product 5 5
Mechanical Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Unintended Movement 5 5
Deformation Due to Compressive Stress 5 5
Chemical Problem 4 4
Separation Failure 4 4
Device Or Device Fragments Location Unknown 4 4
Material Frayed 4 4
Product Quality Problem 4 4
Volume Accuracy Problem 4 4
Pumping Stopped 3 3
Unsealed Device Packaging 3 3
Peeled/Delaminated 3 3
Degraded 3 3
Air Leak 3 3
Blocked Connection 3 3
Failure to Align 3 3
Fail-Safe Problem 3 3
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Premature Separation 3 3
Mechanics Altered 2 2
Torn Material 2 2
Difficult to Open or Close 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
Coiled 2 2
Burst Container or Vessel 2 2
Contamination 2 2
Hole In Material 2 2
Nonstandard Device 2 2
Misconnection 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 770 770
No Known Impact Or Consequence To Patient 282 282
No Clinical Signs, Symptoms or Conditions 248 248
No Patient Involvement 123 123
Foreign Body In Patient 64 64
No Information 59 59
Device Embedded In Tissue or Plaque 53 53
Pain 50 50
Awareness during Anaesthesia 48 48
Insufficient Information 33 33
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
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1
Ambulation Difficulties 1 1
Pregnancy 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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