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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
  1.  K210983  BD Epilor Syringe
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 274 274
2021 168 168
2022 265 265

Device Problems MDRs with this Device Problem Events in those MDRs
Break 425 425
Fluid/Blood Leak 269 269
Leak/Splash 160 160
Defective Device 142 142
Detachment of Device or Device Component 87 87
Bent 82 82
Difficult to Advance 71 71
Physical Resistance 65 65
Patient-Device Incompatibility 64 64
Difficult to Remove 51 51
Infusion or Flow Problem 50 50
Fracture 39 39
Material Fragmentation 39 39
Obstruction of Flow 37 37
Device Contamination with Chemical or Other Material 36 36
Failure to Advance 34 34
Insufficient Information 34 34
No Flow 33 33
Adverse Event Without Identified Device or Use Problem 33 33
Disconnection 33 33
Loose or Intermittent Connection 32 32
Defective Component 30 30
Material Separation 29 29
Difficult to Insert 28 28
Output Problem 28 28
Activation, Positioning or Separation Problem 28 28
Patient Device Interaction Problem 27 27
Detachment Of Device Component 26 26
Device Operates Differently Than Expected 25 25
Physical Resistance/Sticking 25 25
Device Markings/Labelling Problem 23 23
Packaging Problem 21 21
Material Twisted/Bent 21 21
Crack 21 21
Kinked 21 21
Separation Problem 21 21
Missing Value Reason 20 20
Component Missing 20 20
Device Handling Problem 19 19
Appropriate Term/Code Not Available 18 18
Failure to Deliver 16 16
Contamination /Decontamination Problem 14 14
Material Integrity Problem 14 14
Product Quality Problem 14 14
Material Split, Cut or Torn 14 14
Therapeutic or Diagnostic Output Failure 13 13
Material Puncture/Hole 13 13
Entrapment of Device 12 12
Sticking 12 12
Complete Blockage 12 12
Material Too Rigid or Stiff 11 11
Tear, Rip or Hole in Device Packaging 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Mechanical Problem 9 9
Device Dislodged or Dislocated 9 9
Failure to Infuse 9 9
Device Damaged Prior to Use 9 9
Connection Problem 9 9
Positioning Problem 9 9
Material Deformation 8 8
Difficult to Flush 8 8
Use of Device Problem 8 8
Nonstandard Device 7 7
Material Frayed 7 7
Device-Device Incompatibility 7 7
Device Or Device Fragments Location Unknown 7 7
Chemical Problem 6 6
Unraveled Material 6 6
Hole In Material 6 6
Delivered as Unsterile Product 6 6
Insufficient Flow or Under Infusion 6 6
Unintended Movement 6 6
Coiled 5 5
Partial Blockage 5 5
Deformation Due to Compressive Stress 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Protrusion/Extrusion 4 4
Failure to Align 4 4
Separation Failure 4 4
Volume Accuracy Problem 4 4
Uncoiled 4 4
Device Inoperable 4 4
Occlusion Within Device 4 4
Unsealed Device Packaging 4 4
Torn Material 4 4
Premature Separation 3 3
Peeled/Delaminated 3 3
Retraction Problem 3 3
Pumping Stopped 3 3
Stretched 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
Improper Chemical Reaction 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 937 937
No Clinical Signs, Symptoms or Conditions 367 367
No Known Impact Or Consequence To Patient 332 332
No Patient Involvement 137 137
No Information 109 109
Awareness during Anaesthesia 94 94
Device Embedded In Tissue or Plaque 77 77
Foreign Body In Patient 75 75
Pain 58 58
Insufficient Information 35 35
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
Unspecified Vascular Problem 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
Bradycardia 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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