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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
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 371 371
2017 352 352
2018 448 448
2019 472 472
2020 272 272

Device Problems MDRs with this Device Problem Events in those MDRs
Break 356 356
Fluid Leak 230 230
Defective Device 133 133
Leak/Splash 124 124
Catheter 115 115
Bent 82 82
Difficult to Advance 69 69
Physical Resistance 65 65
Infusion or Flow Problem 48 48
Needle 48 48
Patient-Device Incompatibility 46 46
Difficult to Remove 44 44
Detachment of Device or Device Component 42 42
Tip 39 39
Material Fragmentation 35 35
Fracture 34 34
Insufficient Information 34 34
Failure to Advance 34 34
Obstruction of Flow 33 33
Adverse Event Without Identified Device or Use Problem 32 32
Device Contamination with Chemical or Other Material 27 27
Activation, Positioning or SeparationProblem 27 27
Output Problem 27 27
Detachment Of Device Component 26 26
Device Operates Differently Than Expected 25 25
Loose or Intermittent Connection 23 23
Patient Device Interaction Problem 22 22
Kinked 21 21
Difficult to Insert 20 20
Missing Value Reason 20 20
Crack 20 20
Device Handling Problem 19 19
Physical Resistance/Sticking 19 19
Defective Component 18 18
Appropriate Term/Code Not Available 18 18
No Flow 17 17
Material Separation 16 16
Device Markings/Labelling Problem 15 15
Material Twisted/Bent 14 14
Component Missing 14 14
Failure to Deliver 13 13
Disconnection 13 13
Sticking 12 12
Material Integrity Problem 12 12
Packaging Problem 12 12
Filter 12 12
Separation Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Product Quality Problem 11 11
Connector 11 11
Syringe 11 11
Entrapment of Device 10 10
Improper or Incorrect Procedure or Method 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Failure to Infuse 9 9
Material Split, Cut or Torn 9 9
Complete Blockage 9 9
Material Too Rigid or Stiff 9 9
Material Puncture/Hole 9 9
Device Dislodged or Dislocated 8 8
Tear, Rip or Hole in Device Packaging 8 8
Positioning Problem 8 8
Device-Device Incompatibility 7 7
Contamination /Decontamination Problem 7 7
Material Frayed 7 7
Device Or Device Fragments Location Unknown 7 7
Nonstandard Device 7 7
Difficult to Flush 7 7
Tube 6 6
Hole In Material 6 6
Connection Problem 6 6
Chemical Problem 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Deformation 5 5
Partial Blockage 5 5
Coiled 5 5
Unraveled Material 5 5
Delivered as Unsterile Product 5 5
Deformation Due to Compressive Stress 5 5
Failure to Align 4 4
Uncoiled 4 4
Material Protrusion/Extrusion 4 4
Mechanical Problem 4 4
Unsealed Device Packaging 4 4
Clamp 4 4
Torn Material 4 4
Occlusion Within Device 4 4
Device Inoperable 4 4
Device Damaged Prior to Use 3 3
Fail-Safe Problem 3 3
Premature Separation 3 3
Hub 3 3
Air Leak 3 3
Component Incompatible 3 3
Degraded 3 3
Stretched 3 3
Retraction Problem 3 3
Shipping Damage or Problem 3 3
Measurement System Incompatibility 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 928 928
No Known Impact Or Consequence To Patient 332 332
No Patient Involvement 134 134
No Information 108 108
Awareness during Anaesthesia 92 92
Device Embedded In Tissue or Plaque 73 73
Foreign Body In Patient 52 52
Pain 48 48
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
Numbness 14 14
No Clinical Signs, Symptoms or Conditions 13 13
Infiltration into Tissue 11 11
Headache 11 11
Weakness 10 10
Blood Loss 10 10
Perforation 10 10
Needle Stick/Puncture 7 7
Paralysis 5 5
Unspecified Infection 5 5
Underdose 5 5
Therapeutic Effects, Unexpected 4 4
Discomfort 4 4
Therapeutic Response, Decreased 3 3
Insufficient Information 3 3
Dyspnea 3 3
Hematoma 3 3
Skin Irritation 2 2
Swelling 2 2
Arachnoiditis, Spinal 2 2
Incontinence 2 2
Death 2 2
Tingling 2 2
Reaction 1 1
Irritability 1 1
Post Operative Wound Infection 1 1
Exposure to Body Fluids 1 1
Undesired Nerve Stimulation 1 1
Respiratory Distress 1 1
Anxiety 1 1
Injury 1 1
Depression 1 1
Burning Sensation 1 1
Stenosis 1 1
Wound Dehiscence 1 1
Ambulation Difficulties 1 1
Pregnancy 1 1
Sepsis 1 1
Muscle Weakness 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Paresis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Erythema 1 1
Extravasation 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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