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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 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BD
  SUBSTANTIALLY EQUIVALENT 25
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 547
Unraveled material 343
Break 326
Deployment issue 237
Leak 215
Physical resistance 207
Material separation 177
Crack 103
Failure to deploy 101
Detachment of device component 71
Stretched 70
Fluid leak 68
No Known Device Problem 68
Fracture 62
Difficult to remove 60
Use of Device Issue 53
Occlusion within device 44
Migration of device or device component 39
Bent 39
Material deformation 39
Material frayed 38
Other (for use when an appropriate device code cannot be identified) 33
Blockage within device or device component 32
Detachment of device or device component 31
Split 28
Hole in material 24
Material fragmentation 23
Protective measure issue 22
Difficult to advance 21
Difficult to insert 21
Device operates differently than expected 20
Compatibility 19
Material rupture 18
Device, or device fragments remain in patient 16
Sticking 15
Material integrity issue 15
Patient-device incompatibility 15
Failure to advance 15
Device damaged prior to use 13
Device handling issue 12
Incorrect device or component shipped 11
Component missing 11
Cut in material 11
Connection issue 11
Device or device fragments location unknown 11
Loose or intermittent connection 11
Decoupling 11
Air leak 10
Disconnection 9
Device Issue 9
Human-Device Interface Issue 9
Dislodged or dislocated 9
No Information 9
Infusion or flow issue 8
Defective component 8
Buckled material 8
Unknown (for use when the device problem is not known) 7
Entrapment of device or device component 7
Improper or incorrect procedure or method 7
Fitting problem 7
Balloon leak(s) 6
Component(s), broken 6
Obstruction within device 6
Item contaminated during manufacturing or shipping 6
Device-device incompatibility 6
Torn material 6
No code available 5
Tear, rip or hole in device packaging 5
Delamination 5
Device, removal of (non-implant) 5
Contamination during use 5
Mechanical issue 5
Device remains activated 5
Delivered as unsterile product 4
Uncoiled 4
Difficult to deploy 4
Dislodged 4
Aspiration issue 4
Material twisted 4
Device markings issue 3
Foreign material present in device 3
Incompatibility problem 3
Component or accessory incompatibility 3
Malfunction 3
Fail-safe design failure 3
Difficult to flush 3
Burst 3
Tears, rips, holes in device, device material 3
Retraction problem 3
Shielding failure 2
Size incorrect for patient 2
Source, detachment from 2
Tip breakage 2
Insufficient flow or underinfusion 2
Unable to obtain readings 2
Reflux within device 2
Occlusion, incorrect 2
Abnormal 2
Loss of or failure to bond 2
Bleed back 2
Total Device Problems 3631

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 4
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 Jun-12-2017
3 Arrow International Inc II Jun-06-2017
4 Arrow International Inc II Apr-10-2017
5 Arrow International Inc II Jul-06-2016
6 Arrow International Inc II Sep-30-2015
7 Arrow International Inc II Feb-10-2015
8 Arrow International Inc II Jan-22-2015
9 Arrow International Inc II May-19-2014
10 Arrow International Inc II Apr-24-2014
11 Arrow International Inc I Jun-26-2012
12 Arrow International Inc II Jun-19-2012
13 Arrow International Inc II Sep-25-2010
14 Arrow International Inc I Mar-05-2010
15 Arrow International Inc II Aug-10-2009
16 Arrow International Inc II Jun-24-2009
17 Bard Access Systems II Mar-13-2015
18 Bard Access Systems II Jan-23-2014
19 Becton Dickinson & Company II May-18-2016
20 Becton Dickinson & Company II Dec-12-2014
21 Becton Dickinson Medical Systems I Feb-02-2010
22 Centurion Medical Products Corporation I Dec-02-2016
23 Cook Inc. II Dec-12-2016
24 Cook, Inc. I Feb-23-2011
25 Cook, Inc. II Mar-16-2007
26 Nipro Medical Corporation III Jan-06-2016
27 Nipro Medical Corporation II Jun-19-2014
28 Smiths Medical ASD Inc. II Dec-19-2016
29 Terumo Medical Corporation II May-01-2017
30 Tri-State Hospital Supply Corporation I Mar-25-2009
31 Vygon Corporation II Oct-22-2014

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