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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 4
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 182
No Known Device Problem 143
Unknown (for use when the device problem is not known) 135
Material separation 84
Material fragmentation 69
Difficult to remove 53
Device, or device fragments remain in patient 47
Fracture 36
Leak 36
Fluid leak 36
Bent 35
Detachment of device component 30
Unraveled material 29
Physical resistance 28
Difficult to advance 26
Dull 22
Sticking 22
Blockage within device or device component 20
Entrapment of device or device component 17
Torn material 16
Component(s), broken 15
Kinked 15
Foreign material present in device 15
Material frayed 15
Detachment of device or device component 14
Needle, separation 13
Device operates differently than expected 13
Infusion or flow issue 12
No code available 12
Device handling issue 12
Stretched 11
Improper or incorrect procedure or method 11
Loose or intermittent connection 10
Cut in material 9
Device Issue 9
Air leak 9
Tip breakage 9
Product quality issue 8
Failure to cut 8
Device or device fragments location unknown 8
Crack 7
Other (for use when an appropriate device code cannot be identified) 7
Device-device incompatibility 7
Use of Device Issue 7
Obstruction within device 6
Hole in material 6
Split 6
Malposition of device 5
Failure to infuse 5
Deployment issue 5
Explanted 5
Failure to advance 5
Material integrity issue 4
Connection issue 4
Device, removal of (non-implant) 4
Material deformation 4
Nonstandard device or device component 4
Device damaged prior to use 3
Insufficient flow or underinfusion 3
Disconnection 3
Fitting problem 3
Device misassembled during manufacturing or shipping 3
Occlusion within device 3
Difficult to deploy 3
Dislodged or dislocated 3
Tear, rip or hole in device packaging 3
Human-Device Interface Issue 3
Uncoiled 3
Patient-device incompatibility 2
Incompatibility problem 2
Shipping damage or problem 2
Resistance, loss of 2
Coiled 2
Chemical issue 2
Knotted 2
Failure to obtain samples 2
Component or accessory incompatibility 2
Material rigid or stiff 2
Mechanical jam 2
Component incompatible 2
Device clogged 2
Material rupture 2
Manufacturing or shipping issue associated with device 2
No Information 2
Difficult to position 2
Mechanical issue 1
Packaging issue 1
Failure to align 1
Defective item 1
Improper chemical reaction 1
Failure to disconnect 1
Material Distortion 1
Positioning Issue 1
Material Protrusion 1
Failure to deploy 1
Out-of-box failure 1
Catheter withdrawal interference 1
Sharp/jagged/rough/etched/scratched 1
Item contaminated during manufacturing or shipping 1
Aspiration issue 1
Total Device Problems 1467

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 4 0 5 2 2 3 0
Class III 0 0 0 0 0 1 0 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 Nov-10-2016
11 Becton Dickinson & Company II Sep-26-2013
12 Integra Life Sciences Corporation II Sep-21-2009
13 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Sep-21-2016
14 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Aug-29-2016
15 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-17-2013
16 Integra LifeSciences Corp. d.b.a. Integra Pain Management III Jul-05-2012
17 Kimberly-Clark Corporation II Dec-16-2013
18 Smiths Medical ASD, Inc. II Nov-05-2013

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