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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
TELEFLEX INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K161075  Arrow Epidural Catheter Kit

MDR Year MDR Reports MDR Events
2016 372 372
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 416 416
Fluid Leak 266 266
Leak/Splash 152 152
Defective Device 135 135
Bent 82 82
Difficult to Advance 71 71
Physical Resistance 65 65
Patient-Device Incompatibility 62 62
Detachment of Device or Device Component 59 59
Difficult to Remove 51 51
Infusion or Flow Problem 50 50
Material Fragmentation 39 39
Obstruction of Flow 37 37
Fracture 35 35
Failure to Advance 34 34
Device Contamination with Chemical or Other Material 34 34
Insufficient Information 34 34
Adverse Event Without Identified Device or Use Problem 33 33
Loose or Intermittent Connection 30 30
Material Separation 29 29
No Flow 29 29
Output Problem 28 28
Activation, Positioning or SeparationProblem 28 28
Disconnection 27 27
Detachment Of Device Component 26 26
Defective Component 26 26
Device Operates Differently Than Expected 25 25
Difficult to Insert 25 25
Patient Device Interaction Problem 23 23
Physical Resistance/Sticking 23 23
Kinked 21 21
Crack 21 21
Device Markings/Labelling Problem 21 21
Missing Value Reason 20 20
Device Handling Problem 19 19
Material Twisted/Bent 19 19
Appropriate Term/Code Not Available 18 18
Separation Problem 18 18
Packaging Problem 17 17
Component Missing 17 17
Failure to Deliver 14 14
Material Integrity Problem 14 14
Material Split, Cut or Torn 13 13
Therapeutic or Diagnostic Output Failure 12 12
Entrapment of Device 12 12
Material Puncture/Hole 12 12
Sticking 12 12
Product Quality Problem 11 11
Complete Blockage 11 11
Contamination /Decontamination Problem 11 11
Tear, Rip or Hole in Device Packaging 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Material Too Rigid or Stiff 10 10
Improper or Incorrect Procedure or Method 10 10
Failure to Infuse 9 9
Connection Problem 9 9
Positioning Problem 9 9
Device Dislodged or Dislocated 8 8
Use of Device Problem 8 8
Nonstandard Device 7 7
Difficult to Flush 7 7
Material Frayed 7 7
Device-Device Incompatibility 7 7
Material Deformation 7 7
Device Or Device Fragments Location Unknown 7 7
Device Damaged Prior to Use 7 7
Chemical Problem 6 6
Hole In Material 6 6
Mechanical Problem 6 6
Unraveled Material 6 6
Insufficient Flow or Under Infusion 6 6
Unintended Movement 6 6
Delivered as Unsterile Product 5 5
Coiled 5 5
Partial Blockage 5 5
Deformation Due to Compressive Stress 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Material Protrusion/Extrusion 4 4
Failure to Align 4 4
Separation Failure 4 4
Occlusion Within Device 4 4
Unsealed Device Packaging 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
Pumping Stopped 3 3
Peeled/Delaminated 3 3
Retraction Problem 3 3
Shipping Damage or Problem 3 3
Air Leak 3 3
Degraded 3 3
Component Incompatible 3 3
Cut In Material 3 3
Structural Problem 3 3
Blocked Connection 3 3
Fail-Safe Problem 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 Clinical Signs, Symptoms or Conditions 248 248
No Patient Involvement 136 136
No Information 109 109
Awareness during Anaesthesia 93 93
Device Embedded In Tissue or Plaque 77 77
Foreign Body In Patient 74 74
Pain 55 55
Insufficient Information 34 34
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
Numbness 14 14
Infiltration into Tissue 11 11
Perforation 10 10
Weakness 10 10
Blood Loss 10 10
Needle Stick/Puncture 7 7
Underdose 5 5
Paralysis 5 5
Unspecified Infection 5 5
Therapeutic Effects, Unexpected 4 4
Therapeutic Response, Decreased 4 4
Discomfort 4 4
Hematoma 3 3
Dyspnea 3 3
Death 2 2
Failure of Implant 2 2
Incontinence 2 2
Tingling 2 2
Skin Irritation 2 2
Swelling 2 2
Arachnoiditis, Spinal 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pregnancy 1 1
Urethral Stenosis/Stricture 1 1
Reaction 1 1
Irritability 1 1
Post Operative Wound Infection 1 1
Injury 1 1
Depression 1 1
Anxiety 1 1
Ambulation Difficulties 1 1
Low Oxygen Saturation 1 1
Burning Sensation 1 1
Stenosis 1 1
Paresis 1 1
Respiratory Distress 1 1
Sepsis 1 1
Muscle Weakness 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Wound Dehiscence 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Extravasation 1 1
Foreign Body Reaction 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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