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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.  K000235  INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
  2.  K002033  BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P ...
  3.  K011967  BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CH ...
  4.  K011982  0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED ...
  5.  K013073  INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUT ...
  6.  K013800  INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUT ...
  7.  K032843  NEXIVA CLOSED IV CATHETER SYSTEM
  8.  K033500  BD CAREFLOW CENTRAL VENOUS CATHETER
  9.  K042862  BD ONECATH
  10.  K100775  BD INTIMA II CLOSED IV CATHETER
  11.  K102520  BD NEXIVA CLOSED IV CATHETER SYSTEM
  12.  K110443  BD INSYTE AUTOGUARD BC
  13.  K123734  BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
  14.  K143610  BD INTIMA II CLOSED IV CATHETER
  15.  K151698  BD Angiocath IV Catheter, BD Insyte IV Catheter
  16.  K972254  FIRST MIDCATH CATHETER
  17.  K972262  FIRST PICC CATHETER
  18.  K972263  FIRST PICC CATHETER WITH DUAL LUMENS
  19.  K972264  FIRST MIDCATH CATHETER
  20.  K974764  INTROSYTE CATHETER
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
  1.  K000235  INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
  2.  K002033  BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P ...
  3.  K011967  BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CH ...
  4.  K011982  0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED ...
  5.  K013073  INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUT ...
  6.  K013800  INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUT ...
  7.  K032843  NEXIVA CLOSED IV CATHETER SYSTEM
  8.  K033500  BD CAREFLOW CENTRAL VENOUS CATHETER
  9.  K042862  BD ONECATH
  10.  K100775  BD INTIMA II CLOSED IV CATHETER
  11.  K102520  BD NEXIVA CLOSED IV CATHETER SYSTEM
  12.  K110443  BD INSYTE AUTOGUARD BC
  13.  K123734  BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
  14.  K143610  BD INTIMA II CLOSED IV CATHETER
  15.  K151698  BD Angiocath IV Catheter, BD Insyte IV Catheter
  16.  K972254  FIRST MIDCATH CATHETER
  17.  K972262  FIRST PICC CATHETER
  18.  K972263  FIRST PICC CATHETER WITH DUAL LUMENS
  19.  K972264  FIRST MIDCATH CATHETER
  20.  K974764  INTROSYTE CATHETER
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 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 432
Unraveled material 275
Deployment issue 234
Break 220
Physical resistance 162
Leak 136
Material separation 132
Failure to deploy 100
Stretched 65
Detachment of device component 62
Crack 60
Fracture 51
Fluid leak 46
Difficult to remove 46
No Known Device Problem 46
Use of Device Issue 41
Material deformation 36
Other (for use when an appropriate device code cannot be identified) 33
Migration of device or device component 31
Occlusion within device 30
Material frayed 30
Blockage within device or device component 22
Bent 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
Component missing 11
Decoupling 11
Loose or intermittent connection 11
Material rupture 9
Air leak 9
Dislodged or dislocated 9
Human-Device Interface Issue 9
No Information 9
Device operates differently than expected 8
Failure to advance 8
Disconnection 8
Sticking 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
Connection issue 7
Device-device incompatibility 6
Item contaminated during manufacturing or shipping 6
Material integrity issue 6
Balloon leak(s) 6
Component(s), broken 6
Contamination during use 5
Defective component 5
Infusion or flow issue 5
Torn material 5
Device, removal of (non-implant) 5
Tear, rip or hole in device packaging 5
Obstruction within device 4
Buckled material 4
Aspiration issue 4
Material twisted 4
Mechanical issue 4
Delivered as unsterile product 4
Difficult to deploy 4
Dislodged 4
Fail-safe design failure 3
Insufficient flow or underinfusion 3
Fitting problem 3
Tears, rips, holes in device, device material 3
Incompatibility problem 3
No code available 3
Foreign material present in device 3
Uncoiled 3
Malfunction 3
Out-of-box failure 2
Failure to deliver 2
Wire(s), breakage of 2
Defective item 2
Blocked connection 2
Protective measure issue 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
Inflation issue 2
Abnormal 2
Bleed back 2
Loss of or failure to bond 2
Device alarm system issue 1
Balloon burst 1
Total Device Problems 2806

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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