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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 179
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 48
Device, or device fragments remain in patient 47
Fluid leak 36
Leak 35
Fracture 35
Bent 30
Unraveled material 29
Detachment of device component 27
Physical resistance 26
Difficult to advance 25
Dull 22
Blockage within device or device component 20
Sticking 17
Torn material 16
Component(s), broken 15
Kinked 15
Entrapment of device or device component 15
Material frayed 15
Detachment of device or device component 14
Device operates differently than expected 13
Needle, separation 13
Device handling issue 12
No code available 11
Stretched 11
Improper or incorrect procedure or method 11
Loose or intermittent connection 10
Air leak 9
Device Issue 9
Tip breakage 9
Foreign material present in device 9
Infusion or flow issue 9
Cut in material 9
Failure to cut 8
Device or device fragments location unknown 8
Product quality issue 8
Other (for use when an appropriate device code cannot be identified) 7
Use of Device Issue 7
Crack 7
Device-device incompatibility 7
Split 6
Hole in material 6
Obstruction within device 6
Explanted 5
Failure to advance 5
Malposition of device 5
Failure to infuse 5
Deployment issue 5
Material deformation 4
Connection issue 4
Device, removal of (non-implant) 4
Material integrity issue 4
Nonstandard device or device component 4
Occlusion within device 3
Uncoiled 3
Tear, rip or hole in device packaging 3
Device damaged prior to use 3
Insufficient flow or underinfusion 3
Difficult to deploy 3
Disconnection 3
Device misassembled during manufacturing or shipping 3
Dislodged or dislocated 3
Human-Device Interface Issue 3
Patient-device incompatibility 2
Chemical issue 2
Component or accessory incompatibility 2
Failure to obtain samples 2
Mechanical jam 2
No Information 2
Incompatibility problem 2
Component incompatible 2
Device clogged 2
Coiled 2
Knotted 2
Fitting problem 2
Shipping damage or problem 2
Resistance, loss of 2
Material rigid or stiff 2
Material rupture 2
Difficult to position 2
Failure to prime 1
Material puncture 1
Delivered as unsterile product 1
Defective component 1
Component missing 1
Out-of-box failure 1
Looping 1
Mechanical issue 1
Migration of device or device component 1
Misconnection 1
Failure, intermittent 1
Foreign material 1
Intra-cavity procedure, fiberoptic break or fragmentation during 1
Burst 1
Decoupling 1
Disengaged 1
Total Device Problems 1427

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 3
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 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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