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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
ARROW INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 274 274
2021 165 165
2022 270 270
2023 60 60
2024 165 165
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 145 145
Break 140 140
Leak/Splash 86 86
Patient-Device Incompatibility 56 56
Detachment of Device or Device Component 55 55
Lack of Effect 41 41
Disconnection 35 35
Material Separation 29 29
Defective Component 25 25
Material Twisted/Bent 23 23
No Flow 22 22
Complete Blockage 21 21
Packaging Problem 21 21
Material Split, Cut or Torn 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Device Markings/Labelling Problem 15 15
Separation Problem 14 14
Defective Device 14 14
Loose or Intermittent Connection 13 13
Device Contamination with Chemical or Other Material 13 13
Contamination /Decontamination Problem 13 13
Difficult to Remove 12 12
Failure to Advance 11 11
Physical Resistance/Sticking 10 10
Difficult to Insert 10 10
Connection Problem 9 9
Fracture 8 8
Material Fragmentation 8 8
Therapeutic or Diagnostic Output Failure 8 8
Tear, Rip or Hole in Device Packaging 8 8
Obstruction of Flow 7 7
Component Missing 7 7
Crack 7 7
Difficult to Advance 7 7
Insufficient Flow or Under Infusion 6 6
Use of Device Problem 6 6
Material Puncture/Hole 6 6
Device Damaged Prior to Use 6 6
Mechanical Problem 6 6
Product Quality Problem 5 5
Failure to Deliver 5 5
Patient Device Interaction Problem 5 5
Device Dislodged or Dislocated 5 5
Activation, Positioning or Separation Problem 5 5
Unintended Movement 4 4
Separation Failure 4 4
Material Deformation 4 4
Difficult to Flush 4 4
Volume Accuracy Problem 4 4
Blocked Connection 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 563 563
No Consequences Or Impact To Patient 152 152
Insufficient Information 63 63
Foreign Body In Patient 51 51
No Known Impact Or Consequence To Patient 34 34
No Patient Involvement 21 21
Pain 20 20
Awareness during Anaesthesia 20 20
Device Embedded In Tissue or Plaque 11 11
Inadequate Pain Relief 9 9
No Information 9 9
Headache, Lumbar Puncture 7 7
Needle Stick/Puncture 7 7
Headache 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Abscess 3 3
Numbness 3 3
Discomfort 3 3
Anxiety 2 2
Bradycardia 2 2
Twitching 2 2
Chemical Exposure 2 2
Muscle Weakness 2 2
Failure of Implant 2 2
Rash 1 1
Confusion/ Disorientation 1 1
Chest Pain 1 1
Foreign Body Reaction 1 1
Urethral Stenosis/Stricture 1 1
Dyspnea 1 1
Hyperesthesia 1 1
Muscle/Tendon Damage 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Undesired Nerve Stimulation 1 1
Cerebrospinal Fluid Leakage 1 1
Therapeutic Response, Decreased 1 1
Underdose 1 1
No Code Available 1 1
Nausea 1 1
Therapeutic Effects, Unexpected 1 1
Loss of consciousness 1 1
Unspecified Vascular Problem 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1
Nervous System Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Urinary Tract Infection 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 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
5 Smiths Medical ASD Inc. II Apr-29-2020
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