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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 13
  SUBSTANTIALLY EQUIVALENT - KIT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BD
  SUBSTANTIALLY EQUIVALENT 18
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
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 1
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 1
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
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 5
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 6
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAUT
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
TFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 8
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 8
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unraveled material 172
Deployment issue 89
Break 84
Material separation 72
Leak 60
Difficult to remove 40
Kinked 32
Other (for use when an appropriate device code cannot be identified) 28
Failure to deploy 27
Fracture 27
Detachment of device component 27
Fluid leak 25
Blockage within device or device component 20
Material frayed 18
Use of Device Issue 18
Difficult to insert 17
Device, or device fragments remain in patient 16
Migration of device or device component 15
Crack 15
Stretched 15
No Known Device Problem 14
Hole in material 13
Detachment of device or device component 11
Decoupling 11
Incorrect device or component shipped 11
Cut in material 10
Human-Device Interface Issue 9
Physical resistance 8
Occlusion within device 8
Failure to advance 7
Device handling issue 7
Bent 6
Balloon leak(s) 6
Unknown (for use when the device problem is not known) 6
Device-device incompatibility 6
Connection issue 6
Difficult to advance 5
Item contaminated during manufacturing or shipping 5
Tear, rip or hole in device packaging 5
Device, removal of (non-implant) 5
Device or device fragments location unknown 5
Dislodged or dislocated 4
Aspiration issue 4
Material integrity issue 4
Disconnection 4
Entrapment of device or device component 4
Delivered as unsterile product 4
Malfunction 3
Contamination during use 3
Incompatibility problem 3
Defective component 3
Dislodged 3
Fail-safe design failure 3
Component(s), broken 3
Torn material 3
Material fragmentation 3
Tears, rips, holes in device, device material 3
Device operates differently than expected 3
Out-of-box failure 2
Infusion or flow issue 2
Air leak 2
Protective measure issue 2
Inflation issue 2
Wire(s), breakage of 2
Split 2
Source, detachment from 2
Mechanical issue 2
Component missing 2
Foreign material present in device 2
Unable to obtain readings 2
Difficult to deploy 2
Material rupture 2
Loose or intermittent connection 2
Device damaged prior to use 2
Malposition of device 1
Insufficient flow or underinfusion 1
Device displays error message 1
Deflation, cause unknown 1
Reaction 1
Bleed back 1
Device alarm system issue 1
Reflux within device 1
Material deformation 1
Material discolored 1
Improper or incorrect procedure or method 1
Tip breakage 1
Knotted 1
Tube(s), defective 1
Sticking 1
Failure to obtain samples 1
Failure to deliver 1
Compatibility 1
Retraction problem 1
Shielding failure 1
Blocked connection 1
IV catheter pull out 1
Disassembly 1
Balloon burst 1
Defective item 1
Not Applicable 1
Total Device Problems 1096

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 1 1 2 1 1 0
Class II 1 0 2 1 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AM2 PAT INC I Jan-30-2008
2 Arrow International Inc I Jun-26-2012
3 Arrow International Inc II Jun-19-2012
4 Arrow International Inc II Sep-25-2010
5 Arrow International Inc I Mar-05-2010
6 Arrow International Inc II Aug-10-2009
7 Arrow International Inc II Jun-24-2009
8 Becton Dickinson Medical Systems I Feb-02-2010
9 Cook, Inc. I Feb-23-2011
10 Cook, Inc. II Mar-16-2007
11 Tri-State Hospital Supply Corporation I Mar-25-2009

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