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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter,intravascular,therapeutic,short-term less than 30 days
Regulation Description Intravascular catheter.
Product CodeFOZ
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  1.  K052564  VYGON LEADER-FLEX
  2.  K052881  VYGON LATEX FREE BIONECTOR
  3.  K061250  MULTICATH EXPERT
  4.  K070705  MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896. ...
  5.  K141026  LEADERFLEX
  6.  K901640  MULTICATH PLACEMENT KIT
  7.  K941678  BIONECTOR
  8.  K954112  VYGON LIFEVAC MID-LINE TRAY
  9.  K963196  VYGON UMBILICAL CATHETHER INSERTION TRAY
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 13
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BD
  SUBSTANTIALLY EQUIVALENT 20
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 8
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
EASTERN MEDIKIT LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
FLEXICATH LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 5
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KOFU FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 2
LUCENT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MCPHERSON ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDEFILL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 7
NISSHO CORP
  SUBSTANTIALLY EQUIVALENT 2
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PATTON SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHIN CHANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 7
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAUT
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
TFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 9
  1.  K052564  VYGON LEADER-FLEX
  2.  K052881  VYGON LATEX FREE BIONECTOR
  3.  K061250  MULTICATH EXPERT
  4.  K070705  MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896. ...
  5.  K141026  LEADERFLEX
  6.  K901640  MULTICATH PLACEMENT KIT
  7.  K941678  BIONECTOR
  8.  K954112  VYGON LIFEVAC MID-LINE TRAY
  9.  K963196  VYGON UMBILICAL CATHETHER INSERTION TRAY
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 8
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Kinked 419
Unraveled material 271
Deployment issue 234
Break 217
Physical resistance 148
Leak 131
Material separation 127
Failure to deploy 100
Stretched 65
Detachment of device component 62
Crack 60
Fracture 51
Difficult to remove 46
No Known Device Problem 46
Fluid leak 45
Use of Device Issue 39
Material deformation 36
Other (for use when an appropriate device code cannot be identified) 33
Migration of device or device component 31
Material frayed 30
Occlusion within device 29
Bent 21
Blockage within device or device component 21
Detachment of device or device component 21
Split 19
Compatibility 19
Difficult to insert 19
Hole in material 17
Difficult to advance 17
Device, or device fragments remain in patient 16
Material fragmentation 15
Patient-device incompatibility 12
Device handling issue 12
Incorrect device or component shipped 11
Cut in material 11
Device or device fragments location unknown 11
Decoupling 11
Loose or intermittent connection 11
Component missing 10
Dislodged or dislocated 9
Human-Device Interface Issue 9
No Information 9
Material rupture 9
Air leak 9
Disconnection 8
Sticking 8
Device operates differently than expected 8
Failure to advance 8
Unknown (for use when the device problem is not known) 7
Improper or incorrect procedure or method 7
Entrapment of device or device component 7
Balloon leak(s) 6
Component(s), broken 6
Device-device incompatibility 6
Connection issue 6
Item contaminated during manufacturing or shipping 6
Material integrity issue 6
Infusion or flow issue 5
Torn material 5
Device, removal of (non-implant) 5
Tear, rip or hole in device packaging 5
Contamination during use 5
Defective component 5
Mechanical issue 4
Delivered as unsterile product 4
Difficult to deploy 4
Dislodged 4
Obstruction within device 4
Aspiration issue 4
Buckled material 4
Material twisted 4
Incompatibility problem 3
No code available 3
Foreign material present in device 3
Uncoiled 3
Malfunction 3
Fail-safe design failure 3
Insufficient flow or underinfusion 3
Fitting problem 3
Tears, rips, holes in device, device material 3
Tip breakage 2
Shielding failure 2
Source, detachment from 2
Device damaged prior to use 2
Retraction problem 2
Unable to obtain readings 2
Reflux within device 2
Occlusion, incorrect 2
Inflation issue 2
Abnormal 2
Loss of or failure to bond 2
Bleed back 2
Out-of-box failure 2
Failure to deliver 2
Wire(s), breakage of 2
Defective item 2
Blocked connection 2
Protective measure issue 2
Scratched material 1
Temperature issue 1
Total Device Problems 2755

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 1 2 1 1 0 0 0 0
Class II 1 0 2 1 0 1 0 6 4 2
Class III 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 AM2 PAT INC I Jan-30-2008
2 Arrow International Inc II Jul-06-2016
3 Arrow International Inc II Sep-30-2015
4 Arrow International Inc II Feb-10-2015
5 Arrow International Inc II Jan-22-2015
6 Arrow International Inc II May-19-2014
7 Arrow International Inc II Apr-24-2014
8 Arrow International Inc I Jun-26-2012
9 Arrow International Inc II Jun-19-2012
10 Arrow International Inc II Sep-25-2010
11 Arrow International Inc I Mar-05-2010
12 Arrow International Inc II Aug-10-2009
13 Arrow International Inc II Jun-24-2009
14 Bard Access Systems II Mar-13-2015
15 Bard Access Systems II Jan-23-2014
16 Becton Dickinson & Company II May-18-2016
17 Becton Dickinson & Company II Dec-12-2014
18 Becton Dickinson Medical Systems I Feb-02-2010
19 Cook, Inc. I Feb-23-2011
20 Cook, Inc. II Mar-16-2007
21 Nipro Medical Corporation III Jan-06-2016
22 Nipro Medical Corporation II Jun-19-2014
23 Tri-State Hospital Supply Corporation I Mar-25-2009
24 Vygon Corporation II Oct-22-2014

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