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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device port & catheter, implanted, subcutaneous, intravascular
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Product CodeLJT
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 9
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 8
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 25
CLINICAL PLASTIC PRODUCTS SA
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANTADLER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 3
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 5
  SUBSTANTIALLY EQUIVALENT 6
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 16
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 16
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 4
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 15
STD MED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRISTATE
  SUBSTANTIALLY EQUIVALENT - KIT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 82
Detachment of device component 44
Break 33
Leak 25
Material separation 21
Migration of device or device component 20
Difficult to remove 15
Crack 12
Material fragmentation 11
Explanted 11
Suction issue 11
Detachment of device or device component 11
Failure to separate 8
Implant, removal of 8
Device Issue 7
Material integrity issue 7
Device inoperable 6
Patient-device incompatibility 5
Device operates differently than expected 5
Difficult to flush 5
Hole in material 5
Occlusion within device 4
Device, removal of (non-implant) 4
Incorrect device or component shipped 4
Malfunction 4
Obstruction within device 3
Defective item 3
Dislodged or dislocated 3
Unraveled material 3
Source, detachment from 3
Tears, rips, holes in device, device material 3
Port leak(s) 3
Device, or device fragments remain in patient 3
Disconnection 3
Degraded 3
Decoupling 2
Component(s), broken 2
Kinked 2
Rejection 2
Failure to infuse 2
Other (for use when an appropriate device code cannot be identified) 2
Unknown (for use when the device problem is not known) 2
Use of Device Issue 2
Malposition of device 2
Device or device fragments location unknown 2
No Information 2
No code available 2
Device handling issue 1
Mushroomed 1
No Known Device Problem 1
Buckled material 1
Delivery system failure 1
Deployment issue 1
Improper flow or infusion 1
Catheter withdrawal interference 1
Difficult to advance 1
Improper or incorrect procedure or method 1
Stretched 1
Slippage of device or device component 1
Defective component 1
Implant, repositioning of 1
Failure to deliver 1
Device remains implanted 1
Replace 1
Retraction problem 1
Runaway 1
Material rupture 1
Difficult to position 1
Reaction 1
Material opacification 1
Inflation issue 1
Difficult to insert 1
Device maintenance issue 1
Blockage within device or device component 1
Device clogged 1
Disassembly 1
Dislodged 1
Entrapment of device or device component 1
False negative result 1
Fluid leak 1
Failure to flush 1
Material frayed 1
Total Device Problems 457

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 1 0 0 0 0 0 0
Class II 3 1 2 2 2 2 1 1 4 0 1
Class III 0 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, INC II Aug-24-2011
2 Angiodynamics, INC II Sep-01-2009
3 B. Braun Interventional Systems II Aug-13-2015
4 B. Braun Interventional Systems II Jun-27-2011
5 B. Braun Interventional Systems II Sep-03-2009
6 Bard Access Systems II Mar-13-2015
7 Bard Access Systems II Mar-27-2014
8 Bard Access Systems III Mar-01-2012
9 Bard Access Systems II Apr-29-2010
10 Boston Scientific Corp II Apr-14-2007
11 Boston Scientific Corp II Mar-15-2007
12 Cook Vascular Inc. II Sep-17-2008
13 Cook, Inc. I Feb-23-2011
14 Medical Components, Inc dba MedComp II Mar-08-2017
15 Medical Components, Inc dba MedComp II Apr-27-2015
16 Medical Components, Inc dba MedComp II Jun-26-2012
17 Medical Components, Inc dba MedComp II May-18-2012
18 Medical Components, Inc dba MedComp II Aug-17-2010
19 Navilyst Medical, Inc I Jul-01-2010
20 Rita Medical Systems, Inc. II Dec-28-2007
21 Smiths Medical ASD, Inc. II Oct-21-2015
22 Smiths Medical ASD, Inc. II Sep-23-2013

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