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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
  1.  K222341  Arrow 0.2 Micron Flat Filter, GVS
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 472 472
2020 274 274
2021 165 165
2022 270 270
2023 60 60
2024 165 165
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 258 258
Fluid/Blood Leak 235 235
Leak/Splash 115 115
Detachment of Device or Device Component 77 77
Patient-Device Incompatibility 71 71
Lack of Effect 37 37
Defective Component 34 34
Disconnection 34 34
No Flow 29 29
Material Twisted/Bent 28 28
Material Separation 28 28
Packaging Problem 26 26
Failure to Advance 25 25
Complete Blockage 23 23
Device Markings/Labelling Problem 22 22
Separation Problem 21 21
Loose or Intermittent Connection 21 21
Difficult to Insert 21 21
Difficult to Remove 20 20
Activation, Positioning or Separation Problem 19 19
Device Contamination with Chemical or Other Material 17 17
Material Split, Cut or Torn 17 17
Output Problem 17 17
Physical Resistance/Sticking 16 16
Contamination /Decontamination Problem 16 16
Material Fragmentation 15 15
Defective Device 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Obstruction of Flow 14 14
Tear, Rip or Hole in Device Packaging 12 12
Difficult to Advance 11 11
Infusion or Flow Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Puncture/Hole 10 10
Component Missing 10 10
Material Too Rigid or Stiff 9 9
Connection Problem 9 9
Fracture 9 9
Mechanical Problem 7 7
Crack 7 7
Device Dislodged or Dislocated 7 7
Insufficient Flow or Under Infusion 6 6
Use of Device Problem 6 6
Delivered as Unsterile Product 6 6
Appropriate Term/Code Not Available 6 6
Device Damaged Prior to Use 6 6
Unintended Movement 5 5
Insufficient Information 5 5
Patient Device Interaction Problem 5 5
Blocked Connection 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 530 530
No Consequences Or Impact To Patient 338 338
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 106 106
Insufficient Information 59 59
Foreign Body In Patient 55 55
No Information 35 35
Pain 28 28
Device Embedded In Tissue or Plaque 23 23
Awareness during Anaesthesia 21 21
Cerebrospinal Fluid Leakage 16 16
Inadequate Pain Relief 12 12
Infiltration into Tissue 11 11
Headache, Lumbar Puncture 10 10
Blood Loss 10 10
Perforation 10 10
Needle Stick/Puncture 8 8
Headache 7 7
Numbness 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Therapeutic Effects, Unexpected 4 4
Dyspnea 4 4
Discomfort 3 3
No Code Available 3 3
Abscess 3 3
Chemical Exposure 2 2
Unspecified Infection 2 2
Bradycardia 2 2
Underdose 2 2
Patient Problem/Medical Problem 2 2
Anxiety 2 2
Twitching 2 2
Failure of Implant 2 2
Therapeutic Response, Decreased 2 2
Muscle Weakness 2 2
Low Oxygen Saturation 1 1
Injury 1 1
Nervous System Injury 1 1
Rash 1 1
Hypersensitivity/Allergic reaction 1 1
Urethral Stenosis/Stricture 1 1
Urinary Tract Infection 1 1
Unspecified Vascular Problem 1 1
Loss of consciousness 1 1
Chest Pain 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Extravasation 1 1
Low Blood Pressure/ Hypotension 1 1
Hyperesthesia 1 1
Nausea 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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