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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
ARROW INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201356  Plastic LOR Syringe
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 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Break 254 254
Fluid/Blood Leak 230 230
Leak/Splash 114 114
Detachment of Device or Device Component 77 77
Patient-Device Incompatibility 71 71
Defective Component 31 31
Disconnection 30 30
Lack of Effect 30 30
No Flow 29 29
Material Separation 28 28
Material Twisted/Bent 26 26
Packaging Problem 26 26
Failure to Advance 24 24
Device Markings/Labelling Problem 22 22
Separation Problem 21 21
Loose or Intermittent Connection 21 21
Difficult to Insert 20 20
Complete Blockage 19 19
Activation, Positioning or Separation Problem 19 19
Difficult to Remove 19 19
Output Problem 17 17
Device Contamination with Chemical or Other Material 17 17
Physical Resistance/Sticking 16 16
Material Fragmentation 15 15
Material Split, Cut or Torn 14 14
Obstruction of Flow 14 14
Defective Device 14 14
Contamination /Decontamination Problem 14 14
Tear, Rip or Hole in Device Packaging 12 12
Adverse Event Without Identified Device or Use Problem 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 8 8
Fracture 8 8
Mechanical Problem 7 7
Crack 7 7
Device Dislodged or Dislocated 7 7
Delivered as Unsterile Product 6 6
Insufficient Flow or Under Infusion 6 6
Appropriate Term/Code Not Available 6 6
Device Damaged Prior to Use 6 6
Product Quality Problem 5 5
Blocked Connection 5 5
Use of Device Problem 5 5
Patient Device Interaction Problem 5 5
Insufficient Information 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 495 495
No Consequences Or Impact To Patient 338 338
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 106 106
Insufficient Information 54 54
Foreign Body In Patient 53 53
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 7 7
Headache 7 7
Numbness 5 5
Therapeutic Effects, Unexpected 4 4
Dyspnea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Discomfort 3 3
Underdose 2 2
Therapeutic Response, Decreased 2 2
Anxiety 2 2
Bradycardia 2 2
Twitching 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Muscle Weakness 2 2
Chemical Exposure 2 2
Patient Problem/Medical Problem 2 2
Nervous System Injury 1 1
Hyperesthesia 1 1
Unspecified Vascular Problem 1 1
Urethral Stenosis/Stricture 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Chest Pain 1 1
Exposure to Body Fluids 1 1
Urinary Tract Infection 1 1
Tingling 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 Smiths Medical ASD Inc. II Apr-29-2020
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