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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 21
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 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 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 465
Unraveled material 295
Break 248
Deployment issue 234
Physical resistance 195
Leak 156
Material separation 145
Failure to deploy 100
Stretched 66
Crack 63
Detachment of device component 62
Fracture 53
No Known Device Problem 49
Difficult to remove 48
Use of Device Issue 47
Fluid leak 46
Material deformation 38
Other (for use when an appropriate device code cannot be identified) 33
Occlusion within device 33
Migration of device or device component 32
Material frayed 30
Blockage within device or device component 25
Detachment of device or device component 22
Split 21
Bent 21
Compatibility 19
Difficult to insert 19
Hole in material 18
Difficult to advance 17
Material fragmentation 16
Device, or device fragments remain in patient 16
Patient-device incompatibility 14
Device handling issue 12
Incorrect device or component shipped 11
Cut in material 11
Device or device fragments location unknown 11
Component missing 11
Loose or intermittent connection 11
Decoupling 11
Material rupture 10
Sticking 10
Connection issue 10
Dislodged or dislocated 9
Human-Device Interface Issue 9
No Information 9
Air leak 9
Disconnection 8
Device operates differently than expected 8
Failure to advance 8
Entrapment of device or device component 7
Unknown (for use when the device problem is not known) 7
Improper or incorrect procedure or method 7
Balloon leak(s) 6
Component(s), broken 6
Buckled material 6
Device-device incompatibility 6
Material integrity issue 6
Item contaminated during manufacturing or shipping 6
Infusion or flow issue 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
Contamination during use 5
Difficult to deploy 4
Dislodged 4
Fitting problem 4
Mechanical issue 4
Delivered as unsterile product 4
Obstruction within device 4
Aspiration issue 4
Material twisted 4
Incompatibility problem 3
Foreign material present in device 3
Malfunction 3
Uncoiled 3
Insufficient flow or underinfusion 3
Tears, rips, holes in device, device material 3
Fail-safe design failure 3
Inflation issue 2
Burst 2
Abnormal 2
Bleed back 2
Loss of or failure to bond 2
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
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
Total Device Problems 2998

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 1 2 1 1 0 0 0 1
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 Centurion Medical Products Corporation I Dec-02-2016
20 Cook, Inc. I Feb-23-2011
21 Cook, Inc. II Mar-16-2007
22 Nipro Medical Corporation III Jan-06-2016
23 Nipro Medical Corporation II Jun-19-2014
24 Tri-State Hospital Supply Corporation I Mar-25-2009
25 Vygon Corporation II Oct-22-2014

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