Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 448 448
2019 472 472
2020 274 274
2021 168 168
2022 271 271
2023 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 277 277
Fluid/Blood Leak 245 245
Defective Device 132 132
Leak/Splash 125 125
Detachment of Device or Device Component 83 83
Patient-Device Incompatibility 63 63
Insufficient Information 33 33
No Flow 31 31
Disconnection 30 30
Defective Component 30 30
Output Problem 29 29
Difficult to Advance 27 27
Patient Device Interaction Problem 27 27
Physical Resistance/Sticking 27 27
Difficult to Remove 25 25
Failure to Advance 23 23
Loose or Intermittent Connection 22 22
Material Fragmentation 22 22
Device Markings/Labelling Problem 22 22
Packaging Problem 22 22
Material Twisted/Bent 22 22
Separation Problem 21 21
Difficult to Insert 21 21
Material Separation 21 21
Activation, Positioning or Separation Problem 19 19
Device Contamination with Chemical or Other Material 18 18
Missing Value Reason 18 18
Obstruction of Flow 18 18
Material Split, Cut or Torn 16 16
Infusion or Flow Problem 14 14
Contamination /Decontamination Problem 14 14
Failure to Deliver 14 14
Material Puncture/Hole 13 13
Component Missing 12 12
Tear, Rip or Hole in Device Packaging 11 11
Appropriate Term/Code Not Available 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Fracture 10 10
Bent 10 10
Complete Blockage 10 10
Material Too Rigid or Stiff 9 9
Device Operates Differently Than Expected 9 9
Material Integrity Problem 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Crack 8 8
Mechanical Problem 8 8
Device Damaged Prior to Use 7 7
Material Deformation 7 7
Device Dislodged or Dislocated 7 7
Connection Problem 7 7
Positioning Problem 6 6
Product Quality Problem 6 6
Use of Device Problem 6 6
Insufficient Flow or Under Infusion 6 6
Delivered as Unsterile Product 6 6
Difficult to Flush 6 6
Entrapment of Device 5 5
Failure to Infuse 5 5
Physical Resistance 5 5
Deformation Due to Compressive Stress 5 5
Unintended Movement 5 5
Chemical Problem 4 4
Separation Failure 4 4
Volume Accuracy Problem 4 4
Detachment Of Device Component 4 4
Pumping Stopped 3 3
Unsealed Device Packaging 3 3
Material Frayed 3 3
Improper or Incorrect Procedure or Method 3 3
Device Or Device Fragments Location Unknown 3 3
Blocked Connection 3 3
Material Protrusion/Extrusion 3 3
Measurement System Incompatibility 3 3
Fail-Safe Problem 3 3
Premature Separation 3 3
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Improper Flow or Infusion 2 2
Mechanics Altered 2 2
Difficult to Open or Close 2 2
Structural Problem 2 2
Dull, Blunt 2 2
Unraveled Material 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Peeled/Delaminated 2 2
Misconnection 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Contamination 2 2
Material Disintegration 1 1
Flushing Problem 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1
Coiled 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Occlusion Within Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 586 586
No Clinical Signs, Symptoms or Conditions 392 392
No Known Impact Or Consequence To Patient 221 221
No Patient Involvement 107 107
Foreign Body In Patient 53 53
No Information 45 45
Pain 42 42
Awareness during Anaesthesia 41 41
Insufficient Information 37 37
Device Embedded In Tissue or Plaque 36 36
Patient Problem/Medical Problem 22 22
Cerebrospinal Fluid Leakage 16 16
Headache 14 14
Numbness 13 13
Headache, Lumbar Puncture 12 12
Infiltration into Tissue 11 11
Inadequate Pain Relief 10 10
Weakness 10 10
Perforation 10 10
Blood Loss 10 10
No Code Available 9 9
Needle Stick/Puncture 7 7
Underdose 5 5
Therapeutic Effects, Unexpected 4 4
Paralysis 3 3
Dyspnea 3 3
Hematoma 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Therapeutic Response, Decreased 2 2
Discomfort 2 2
Injury 1 1
Arachnoiditis, Spinal 1 1
Stenosis 1 1
Paresis 1 1
Tingling 1 1
Sepsis 1 1
Skin Irritation 1 1
Swelling 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Muscle Weakness 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Vascular Problem 1 1
Urethral Stenosis/Stricture 1 1
Ambulation Difficulties 1 1
Low Oxygen Saturation 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 Smiths Medical ASD Inc. II Apr-29-2020
-
-