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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
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 23
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 10
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 2
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 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 8
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 7
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
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 8
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Kinked 503
Unraveled material 312
Break 266
Deployment issue 235
Physical resistance 199
Leak 178
Material separation 157
Failure to deploy 101
Crack 83
Stretched 66
Detachment of device component 63
No Known Device Problem 56
Fracture 55
Use of Device Issue 52
Difficult to remove 50
Fluid leak 50
Material deformation 38
Occlusion within device 37
Material frayed 36
Migration of device or device component 34
Other (for use when an appropriate device code cannot be identified) 33
Blockage within device or device component 27
Bent 24
Split 24
Detachment of device or device component 22
Difficult to advance 19
Compatibility 19
Hole in material 19
Difficult to insert 19
Material fragmentation 17
Device, or device fragments remain in patient 16
Material rupture 16
Patient-device incompatibility 15
Device handling issue 12
Incorrect device or component shipped 11
Device or device fragments location unknown 11
Cut in material 11
Component missing 11
Loose or intermittent connection 11
Decoupling 11
Sticking 10
Connection issue 10
Device operates differently than expected 9
Failure to advance 9
Dislodged or dislocated 9
Human-Device Interface Issue 9
No Information 9
Air leak 8
Disconnection 8
Entrapment of device or device component 7
Improper or incorrect procedure or method 7
Unknown (for use when the device problem is not known) 7
Device damaged prior to use 7
Buckled material 6
Infusion or flow issue 6
Item contaminated during manufacturing or shipping 6
Device-device incompatibility 6
Material integrity issue 6
Fitting problem 6
Balloon leak(s) 6
Component(s), broken 6
Contamination during use 5
Device remains activated 5
No code available 5
Torn material 5
Device, removal of (non-implant) 5
Defective component 5
Tear, rip or hole in device packaging 5
Aspiration issue 4
Obstruction within device 4
Material twisted 4
Delivered as unsterile product 4
Mechanical issue 4
Difficult to deploy 4
Dislodged 4
Fail-safe design failure 3
Burst 3
Uncoiled 3
Tears, rips, holes in device, device material 3
Incompatibility problem 3
Foreign material present in device 3
Component or accessory incompatibility 3
Malfunction 3
Defective item 2
Out-of-box failure 2
Failure to deliver 2
Wire(s), breakage of 2
Blocked connection 2
Protective measure issue 2
Tip breakage 2
Insufficient flow or underinfusion 2
Retraction problem 2
Shielding failure 2
Size incorrect for patient 2
Source, detachment from 2
Occlusion, incorrect 2
Unable to obtain readings 2
Reflux within device 2
Abnormal 2
Bleed back 2
Total Device Problems 3197

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 1 2 1 1 0 0 0 1 0
Class II 1 0 2 1 0 1 0 6 4 4 0
Class III 0 0 0 0 0 0 0 0 0 1 0

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 Centurion Medical Products Corporation I Dec-02-2016
20 Cook Inc. II Dec-12-2016
21 Cook, Inc. I Feb-23-2011
22 Cook, Inc. II Mar-16-2007
23 Nipro Medical Corporation III Jan-06-2016
24 Nipro Medical Corporation II Jun-19-2014
25 Smiths Medical ASD Inc. II Dec-19-2016
26 Tri-State Hospital Supply Corporation I Mar-25-2009
27 Vygon Corporation II Oct-22-2014

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