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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
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 14
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT 5
BD
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT 8
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 11
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 3
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 142
Unknown (for use when the device problem is not known) 135
Break 133
Material separation 81
Material fragmentation 68
Device, or device fragments remain in patient 47
Difficult to remove 42
Fracture 30
Unraveled material 26
Fluid leak 25
Leak 25
Detachment of device component 24
Dull 22
Blockage within device or device component 19
Sticking 16
Component(s), broken 15
Torn material 15
Bent 13
Needle, separation 13
Entrapment of device or device component 12
Material frayed 12
Device operates differently than expected 12
Detachment of device or device component 11
Stretched 11
Kinked 10
Difficult to advance 10
No code available 9
Air leak 9
Tip breakage 9
Cut in material 9
Device Issue 8
Physical resistance 8
Failure to cut 8
Device or device fragments location unknown 7
Foreign material present in device 7
Other (for use when an appropriate device code cannot be identified) 7
Improper or incorrect procedure or method 7
Use of Device Issue 6
Hole in material 6
Split 6
Malposition of device 5
Explanted 5
Crack 5
Failure to advance 5
Product quality issue 5
Failure to infuse 4
Device, removal of (non-implant) 4
Deployment issue 4
Material deformation 4
Device handling issue 4
Dislodged or dislocated 3
Material integrity issue 3
Device-device incompatibility 3
Obstruction within device 3
Insufficient flow or underinfusion 3
Device damaged prior to use 3
Occlusion within device 3
Difficult to deploy 3
Disconnection 2
Difficult to position 2
Resistance, loss of 2
Material rigid or stiff 2
Material rupture 2
Fitting problem 2
Failure to obtain samples 2
Connection issue 2
Device misassembled during manufacturing or shipping 2
Human-Device Interface Issue 2
Incompatibility problem 1
Infusion or flow issue 1
Item contaminated during manufacturing or shipping 1
Difficult to open or close 1
Material twisted 1
Mechanical jam 1
Material Distortion 1
No Information 1
Packaging issue 1
Positioning Issue 1
Catheter withdrawal interference 1
Aspiration issue 1
Component or accessory incompatibility 1
Failure to disconnect 1
Sharp/jagged/rough/etched/scratched 1
Defective item 1
Decreased sensitivity 1
Tear, rip or hole in device packaging 1
Defective component 1
Component missing 1
Out-of-box failure 1
Failure to prime 1
Material puncture 1
Shipping damage or problem 1
Uncoiled 1
Disengaged 1
Failure to deploy 1
Decoupling 1
Component incompatible 1
Burst 1
Device clogged 1
Coiled 1
Total Device Problems 1196

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 4 0 5 2 2 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-10-2015
2 Arrow International Inc II Dec-12-2014
3 Arrow International Inc II Oct-22-2014
4 Arrow International Inc II Dec-19-2013
5 Arrow International Inc II Nov-30-2011
6 Arrow International Inc II Jul-29-2011
7 Arrow International Inc II Feb-17-2011
8 Arrow International Inc II Feb-01-2011
9 B. Braun Medical, Inc. II Oct-21-2015
10 Becton Dickinson & Company II Sep-26-2013
11 Integra Life Sciences Corporation II Sep-21-2009
12 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-17-2013
13 Integra LifeSciences Corp. d.b.a. Integra Pain Management III Jul-05-2012
14 Kimberly-Clark Corporation II Dec-16-2013
15 Smiths Medical ASD, Inc. II Nov-05-2013

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