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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, implanted
Regulation Description Blood access device and accessories.
Product CodeMSD
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - KIT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT 6
CARDIOMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 9
MEDCOMP
  SUBSTANTIALLY EQUIVALENT - KIT 6
  SUBSTANTIALLY EQUIVALENT 7
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 5
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
VASCA INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 268
Crack 191
Hole in material 116
Fluid leak 101
Break 89
Device operates differently than expected 51
Migration of device or device component 45
Fracture 42
Air leak 26
Growth, will not support 23
Material separation 19
Failure to Adhere or Bond 18
Device, removal of (non-implant) 17
Detachment of device or device component 15
Material disintegration 14
Kinked 14
Occlusion within device 14
Detachment of device component 12
Restricted flowrate 11
Difficult to remove 11
Use of Device Issue 11
Split 11
Cut in material 10
Material deformation 9
Disconnection 9
No Known Device Problem 8
No Information 8
Infusion or flow issue 7
Inaccurate flowrate 7
Unknown (for use when the device problem is not known) 7
Component(s), broken 6
Bleed back 6
Connection issue 6
Torn material 6
Bent 5
Decoupling 5
Improper or incorrect procedure or method 5
Difficult to insert 5
Material rupture 4
Unraveled material 4
Contamination during use 4
Material fragmentation 4
Adaptor, failure of 4
Blockage within device or device component 4
Other (for use when an appropriate device code cannot be identified) 4
Implant, removal of 4
Human-Device Interface Issue 3
Coagulation in device or device ingredient 3
Insufficient flow or underinfusion 3
Sticking 3
Material puncture 3
Loose or intermittent connection 3
Mechanical issue 2
Delivered as unsterile product 2
Difficult to position 2
Device inoperable 2
Tears, rips, holes in device, device material 2
Material perforation 2
Device damaged prior to use 2
Volume accuracy issue 2
Collapse 2
Device clogged 2
Material frayed 2
Improper flow or infusion 2
Device-device incompatibility 2
Mechanics altered 2
Material Distortion 2
Defective item 2
Device or device fragments location unknown 2
Unintended movement 2
Positioning Issue 2
Scratched material 2
Noise, Audible 1
Pressure issue 1
Malposition of device 1
Implant breakage or physical damage 1
Patient-device incompatibility 1
Blocked connection 1
Failure to infuse 1
Malfunction 1
Failure to disconnect 1
Failure to separate 1
Incorrect or inadequate test results 1
Low readings 1
Structural problem 1
Failure to obtain samples 1
Material integrity issue 1
Material Protrusion 1
Moisture or humidity problem 1
No flow 1
Packaging issue 1
Dislodged or dislocated 1
Foreign material present in device 1
Inadequate user interface 1
Foreign material 1
Failure to deploy 1
Disassembly 1
Dislodged 1
Entrapment of device or device component 1
Explanted 1
Total Device Problems 1346

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 0 2 2 1 2 2 0 2 3 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Jan-12-2012
2 Angiodynamics, Inc. II Jan-11-2012
3 Angiodynamics, Inc. II Jun-04-2010
4 Angiodynamics, Inc. II Sep-24-2008
5 Argon Medical Devices, Inc II Sep-24-2014
6 Arrow International Inc II Jan-22-2015
7 Arrow International Inc I Jul-30-2011
8 Arrow International Inc II Sep-17-2008
9 Bard Access Systems III Aug-27-2012
10 Covidien LLC II Jul-01-2015
11 Medical Components, Inc dba MedComp II Mar-30-2015
12 Medical Components, Inc dba MedComp II Sep-04-2014
13 Medical Components, Inc dba MedComp II Jun-28-2011
14 Medical Components, Inc dba MedComp II Nov-10-2009
15 R4 Vascular Inc II Jun-06-2011
16 Spire Biomedical, Inc. II Nov-17-2009

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