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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
  1.  K210983  BD Epilor Syringe
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 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 261 261
Fluid/Blood Leak 241 241
Leak/Splash 115 115
Detachment of Device or Device Component 77 77
Patient-Device Incompatibility 71 71
Lack of Effect 39 39
Disconnection 37 37
Defective Component 35 35
No Flow 29 29
Material Separation 28 28
Material Twisted/Bent 28 28
Packaging Problem 26 26
Failure to Advance 25 25
Device Markings/Labelling Problem 24 24
Complete Blockage 24 24
Separation Problem 23 23
Loose or Intermittent Connection 22 22
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
Adverse Event Without Identified Device or Use Problem 15 15
Material Fragmentation 15 15
Defective Device 15 15
Obstruction of Flow 14 14
Tear, Rip or Hole in Device Packaging 12 12
Infusion or Flow Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Difficult to Advance 11 11
Component Missing 10 10
Material Puncture/Hole 10 10
Connection Problem 9 9
Material Too Rigid or Stiff 9 9
Fracture 9 9
Crack 8 8
Device Dislodged or Dislocated 7 7
Mechanical Problem 7 7
Device Damaged Prior to Use 6 6
Use of Device Problem 6 6
Appropriate Term/Code Not Available 6 6
Insufficient Flow or Under Infusion 6 6
Delivered as Unsterile Product 6 6
Insufficient Information 5 5
Unintended Movement 5 5
Material Integrity Problem 5 5
Failure to Deliver 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 551 551
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 56 56
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
Perforation 10 10
Headache, Lumbar Puncture 10 10
Blood Loss 10 10
Needle Stick/Puncture 8 8
Headache 7 7
Numbness 5 5
Dyspnea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Therapeutic Effects, Unexpected 4 4
Discomfort 3 3
No Code Available 3 3
Abscess 3 3
Chemical Exposure 2 2
Muscle Weakness 2 2
Twitching 2 2
Failure of Implant 2 2
Bradycardia 2 2
Anxiety 2 2
Therapeutic Response, Decreased 2 2
Underdose 2 2
Patient Problem/Medical Problem 2 2
Unspecified Infection 2 2
Urethral Stenosis/Stricture 1 1
Foreign Body Reaction 1 1
Confusion/ Disorientation 1 1
Rash 1 1
Injury 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Nausea 1 1
Exposure to Body Fluids 1 1
Chest Pain 1 1
Tingling 1 1
Hyperesthesia 1 1
Extravasation 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Neuropathy 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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