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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
  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 167 167

Device Problems MDRs with this Device Problem Events in those MDRs
Break 383 383
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 53 53
Detachment of Device or Device Component 52 52
Infusion or Flow Problem 50 50
Difficult to Remove 45 45
Material Fragmentation 39 39
Obstruction of Flow 36 36
Fracture 35 35
Failure to Advance 34 34
Insufficient Information 34 34
Adverse Event Without Identified Device or Use Problem 33 33
Device Contamination with Chemical or Other Material 33 33
Output Problem 28 28
Activation, Positioning or SeparationProblem 28 28
Loose or Intermittent Connection 26 26
Detachment Of Device Component 26 26
No Flow 25 25
Device Operates Differently Than Expected 25 25
Patient Device Interaction Problem 22 22
Crack 21 21
Kinked 21 21
Difficult to Insert 20 20
Material Separation 20 20
Device Markings/Labelling Problem 20 20
Defective Component 20 20
Physical Resistance/Sticking 20 20
Missing Value Reason 20 20
Device Handling Problem 19 19
Disconnection 19 19
Appropriate Term/Code Not Available 18 18
Component Missing 16 16
Packaging Problem 15 15
Material Twisted/Bent 15 15
Material Integrity Problem 14 14
Failure to Deliver 14 14
Separation Problem 13 13
Sticking 12 12
Product Quality Problem 11 11
Material Split, Cut or Torn 11 11
Therapeutic or Diagnostic Output Failure 11 11
Improper or Incorrect Procedure or Method 10 10
Material Puncture/Hole 10 10
Complete Blockage 10 10
Entrapment of Device 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Positioning Problem 9 9
Failure to Infuse 9 9
Contamination /Decontamination Problem 9 9
Material Too Rigid or Stiff 9 9
Use of Device Problem 8 8
Tear, Rip or Hole in Device Packaging 8 8
Device Dislodged or Dislocated 8 8
Device-Device Incompatibility 7 7
Material Deformation 7 7
Device Or Device Fragments Location Unknown 7 7
Nonstandard Device 7 7
Difficult to Flush 7 7
Material Frayed 7 7
Hole In Material 6 6
Unraveled Material 6 6
Chemical Problem 6 6
Connection Problem 6 6
Deformation Due to Compressive Stress 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Insufficient Flow or Under Infusion 5 5
Delivered as Unsterile Product 5 5
Coiled 5 5
Partial Blockage 5 5
Mechanical Problem 4 4
Occlusion Within Device 4 4
Unsealed Device Packaging 4 4
Uncoiled 4 4
Device Inoperable 4 4
Material Protrusion/Extrusion 4 4
Separation Failure 4 4
Failure to Align 4 4
Torn Material 4 4
Unintended Movement 4 4
Premature Separation 3 3
Device Damaged Prior to Use 3 3
Cut In Material 3 3
Structural Problem 3 3
Measurement System Incompatibility 3 3
Fail-Safe Problem 3 3
Stretched 3 3
Volume Accuracy Problem 3 3
Peeled/Delaminated 3 3
Pumping Stopped 3 3
Retraction Problem 3 3
Shipping Damage or Problem 3 3
Air Leak 3 3
Degraded 3 3
Component Incompatible 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 136 136
No Patient Involvement 136 136
No Information 109 109
Awareness during Anaesthesia 93 93
Device Embedded In Tissue or Plaque 75 75
Foreign Body In Patient 63 63
Pain 51 51
Headache, Lumbar Puncture 30 30
Patient Problem/Medical Problem 22 22
No Code Available 21 21
Insufficient Information 19 19
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
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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