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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
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 284
Fluid Leak 193
Defective Device 125
Leak/Splash 103
Adverse Event Without Identified Device or Use Problem 99
Bent 80
Catheter 72
Difficult to Advance 65
Physical Resistance 54
Infusion or Flow Problem 47
Material Fragmentation 35
Insufficient Information 34
Needle 32
Fracture 32
Difficult to Remove 30
Obstruction of Flow 30
Detachment of Device or Device Component 29
Output Problem 27
Patient-Device Incompatibility 24
Activation, Positioning or SeparationProblem 24
Failure to Advance 23
Patient Device Interaction Problem 22
Missing Value Reason 20
Device Contamination with Chemical or Other Material 20
Device Handling Problem 19
Loose or Intermittent Connection 17
Crack 16
Difficult to Insert 15
Kinked 15
Defective Component 14
Material Separation 14
No Flow 14
Failure to Deliver 13
Detachment Of Device Component 13
Sticking 12
Appropriate Term/Code Not Available 12
Physical Resistance/Sticking 11
Product Quality Problem 11
Material Twisted/Bent 10
Packaging Problem 10
Device Operates Differently Than Expected 10
Separation Problem 10
Entrapment of Device 9
Improper or Incorrect Procedure or Method 9
Failure to Infuse 9
Tear, Rip or Hole in Device Packaging 9
Material Integrity Problem 9
Complete Blockage 8
Material Puncture/Hole 8
Device Markings/Labelling Problem 8
Device-Device Incompatibility 7
Material Frayed 7
Connection Problem 7
Material Split, Cut or Torn 7
Nonstandard Device 7
Filter 7
Connector 7
Device Or Device Fragments Location Unknown 7
Material Too Rigid or Stiff 7
Material Deformation 7
Tip 7
Chemical Problem 6
Syringe 6
Difficult to Flush 6
Device Contaminated During Manufacture or Shipping 6
Torn Material 5
Deformation Due to Compressive Stress 5
Device Misassembled During Manufacturing /Shipping 5
Manufacturing, Packaging or Shipping Problem 5
Disconnection 4
Failure to Align 4
Split 4
Uncoiled 4
Device Dislodged or Dislocated 4
Unraveled Material 4
Cut In Material 3
Premature Separation 3
Positioning Problem 3
Stretched 3
Contamination /Decontamination Problem 3
Insufficient Flow or Under Infusion 3
Degraded 3
Air Leak 3
Fail-Safe Problem 3
Measurement System Incompatibility 3
Improper Chemical Reaction 2
Material Protrusion/Extrusion 2
Difficult to Open or Close 2
Difficult To Position 2
Tee 2
Shipping Damage or Problem 2
Structural Problem 2
Human-Device Interface Problem 2
Human Factors Issue 2
Partial Blockage 2
Mechanical Problem 2
Delivered as Unsterile Product 2
Occlusion Within Device 2
Material Rupture 2
Coiled 2
Total Device Problems 2014

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Arrow International Inc II Jan-24-2020
3 Arrow International Inc II May-30-2018
4 Arrow International Inc II Feb-10-2015
5 B. Braun Medical, Inc. II Oct-21-2015
6 Becton Dickinson & Company II Nov-10-2016
7 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Sep-21-2016
8 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Aug-29-2016
9 Smiths Medical ASD Inc. II Apr-29-2020

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