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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, administration, intravascular
Regulation Description Intravascular administration set.
Product CodeFPA
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
  1.  K011858  INTERLINK THREADED LOCK CANNULA
  2.  K013621  BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
  3.  K033350  BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH F ...
  4.  K050207  BD POSIFLOW POSITIVE DISPLACEMENT VALVE
  5.  K150059  BD FlowSmart Set
  6.  K153257  BD FlowSmart Set, MiniMed Pro-Set
  7.  K160651  BD FlowSmart Set, MiniMed Pro-Set
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 31
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIMAS
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
AVAIL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 22
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 57
BD
  SUBSTANTIALLY EQUIVALENT 7
  1.  K011858  INTERLINK THREADED LOCK CANNULA
  2.  K013621  BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
  3.  K033350  BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH F ...
  4.  K050207  BD POSIFLOW POSITIVE DISPLACEMENT VALVE
  5.  K150059  BD FlowSmart Set
  6.  K153257  BD FlowSmart Set, MiniMed Pro-Set
  7.  K160651  BD FlowSmart Set, MiniMed Pro-Set
BIOMEDIX
  SUBSTANTIALLY EQUIVALENT 3
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CARDIOMED
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
CODAN US CORP.
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DRAGON HEART MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 6
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 13
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 9
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 25
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 12
INNOVATIVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
JMS
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
LABORATOIRES PEROUSE
  SUBSTANTIALLY EQUIVALENT 1
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
LEVENTON, S.A.
  SUBSTANTIALLY EQUIVALENT 1
Lifemed of California
  SUBSTANTIALLY EQUIVALENT 2
MAERSK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARCAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 11
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 2
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 5
MEDEX
  SUBSTANTIALLY EQUIVALENT 9
MEDIKMARK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 14
MEINNTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MIGADA PLANT
  SUBSTANTIALLY EQUIVALENT 1
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NEXUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 13
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 6
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
RYMED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 15
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 13
TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 8
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 4
VENETEC
  SUBSTANTIALLY EQUIVALENT 2
VENUSA LTD.
  SUBSTANTIALLY EQUIVALENT 5
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 8
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 4060
Leak 1585
Disconnection 1005
Material separation 861
Break 786
Failure to Adhere or Bond 603
Crack 580
Reflux within device 481
Device operates differently than expected 480
Detachment of device component 454
Failure to prime 339
No flow 323
Detachment of device or device component 290
Failure to deliver 250
Infusion or flow issue 236
Material deformation 224
Connection issue 208
Overdelivery 183
Hole in material 168
Kinked 162
Sticking 161
Material rupture 157
Occlusion within device 155
Failure to infuse 153
Bent 148
Air leak 146
No Known Device Problem 145
Valve(s), failure of 132
Improper flow or infusion 130
Excess flow or overinfusion 118
Free or unrestricted flow 106
Accuracy rate 105
Blockage within device or device component 93
Difficult or delayed activation 92
Material fragmentation 91
Cut in material 88
Component(s), broken 84
Insufficient flow or underinfusion 84
Buckled material 82
Material integrity issue 74
Foreign material present in device 73
Unknown (for use when the device problem is not known) 73
Component missing 68
No Information 65
Dislodged or dislocated 61
Device displays error message 60
Loss of or failure to bond 60
Fitting problem 55
Particulates 55
Device, or device fragments remain in patient 54
Material puncture 53
Filling problem 47
Fracture 43
Device alarm system issue 43
Tube(s), defective 42
Mechanical issue 41
Failure to separate 41
Loose or intermittent connection 40
Failure to reset 35
Other (for use when an appropriate device code cannot be identified) 33
Packaging issue 33
Improper or incorrect procedure or method 31
Stretched 31
Product quality issue 30
Failure to advance 29
Defective item 27
Failure to deploy 27
Use of Device Issue 26
Migration of device or device component 25
Failure to disconnect 25
Material Distortion 25
Melted 24
Inaccurate flowrate 24
Protective measure issue 21
Deployment issue 20
Not Applicable 19
Fail-safe design failure 19
Bleed back 19
Volume accuracy issue 19
Defective component 19
No code available 18
Split 18
Difficult to remove 17
Inaccurate delivery 16
Burst 16
Obstruction within device 15
Device or device fragments location unknown 15
Fail-safe mechanism issue 15
Tears, rips, holes in device, device material 14
Tube(s), buckling of 13
Retraction problem 13
Material disintegration 13
Delivery system failure 13
Improper chemical reaction 12
Connection error 11
Shelf life exceeded 11
Underdelivery 11
Device contamination with blood or blood product 11
Safety interlock(s) inadequate 9
Filter leak(s) 9
Total Device Problems 17427

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 5 0 1 1 0 0 0
Class II 9 4 5 10 7 9 13 16 12 12
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arizant Healthcare, Inc II Aug-18-2007
2 Arrow International Inc I Mar-30-2010
3 Arrow International Inc II Jun-24-2009
4 Asante Solutions, Inc. II Dec-27-2013
5 B. Braun Medical, Inc. II Jul-09-2014
6 B. Braun Medical, Inc. II Feb-18-2014
7 B. Braun Medical, Inc. II Jan-26-2010
8 B. Braun Medical, Inc. II Jun-05-2009
9 B. Braun Medical, Inc. II Oct-24-2008
10 B. Braun Medical, Inc. II Sep-23-2008
11 B. Braun Medical, Inc. II May-31-2007
12 Bard Access Systems II Apr-30-2015
13 Bard Access Systems II Mar-13-2015
14 Bard Access Systems II Feb-26-2010
15 Baxter Healthcare Corp II Oct-16-2015
16 Baxter Healthcare Corp II Sep-09-2014
17 Baxter Healthcare Corp. II Aug-29-2016
18 Baxter Healthcare Corp. II Jan-07-2016
19 Baxter Healthcare Corp. II Oct-30-2013
20 Baxter Healthcare Corp. II Oct-29-2013
21 Baxter Healthcare Corp. II May-07-2013
22 Baxter Healthcare Corp. I Oct-09-2012
23 Baxter Healthcare Corp. II Jan-11-2012
24 Baxter Healthcare Corp. II Aug-03-2011
25 Baxter Healthcare Corp. II Jul-15-2011
26 Baxter Healthcare Corp. II Jun-29-2011
27 Baxter Healthcare Corp. II Dec-01-2010
28 Baxter Healthcare Corp. II Oct-27-2010
29 Baxter Healthcare Corp. II Oct-15-2010
30 Baxter Healthcare Corp. II Dec-09-2009
31 Baxter Healthcare Corp. II Mar-14-2007
32 Becton Dickinson & Company II Mar-25-2015
33 Becton Dickinson Medical Systems I Feb-02-2010
34 Biomedix, Inc. II Oct-06-2014
35 C.R. Bard, Inc., Urological Division II Jun-29-2009
36 Cardinal Health 303 Inc DBA Alaris Products II Nov-08-2007
37 CareFusion 303, Inc. II Mar-17-2016
38 CareFusion 303, Inc. II Dec-17-2015
39 CareFusion 303, Inc. II Nov-05-2015
40 CareFusion 303, Inc. II Feb-04-2015
41 CareFusion 303, Inc. II Jul-09-2014
42 CareFusion 303, Inc. II Apr-16-2014
43 CareFusion 303, Inc. II Feb-04-2014
44 CareFusion 303, Inc. II Feb-03-2014
45 CareFusion 303, Inc. II Dec-04-2013
46 CareFusion 303, Inc. II Dec-03-2013
47 CareFusion 303, Inc. II Sep-26-2013
48 CareFusion 303, Inc. II Sep-26-2013
49 CareFusion 303, Inc. II Sep-26-2013
50 Carefusion 303 Inc II Feb-15-2013
51 Carefusion 303, Inc. II Jun-29-2011
52 Carmel Pharma, Inc. II Aug-22-2007
53 Centurion Medical Products Corporation II Feb-23-2016
54 Churchill Medical Systems, Inc. II Apr-21-2015
55 Churchill Medical Systems, Inc. II Jan-23-2014
56 Churchill Medical Systems, Inc. II Sep-18-2013
57 Churchill Medical Systems, Inc. II Mar-06-2013
58 Churchill Medical Systems, Inc. II Feb-16-2011
59 Churchill Medical Systems, Inc. II May-21-2010
60 Codan Us Corporation II Jul-10-2014
61 ConMed Corporation II Jan-11-2012
62 ConMed Corporation II Jan-11-2012
63 Curlin Medical Llc II Aug-07-2007
64 Exelint International Co. I Jan-22-2010
65 Global Healthcare Inc II Feb-03-2016
66 Hospira Inc. II Jun-29-2016
67 Hospira Inc. II Mar-06-2014
68 Hospira Inc. II Jul-18-2013
69 Hospira Inc. II Jul-25-2012
70 Hospira Inc. II Jan-19-2012
71 Hospira Inc. II Nov-25-2011
72 Hospira Inc. II Sep-29-2010
73 Hospira Inc. II Apr-15-2010
74 Hospira Inc. II Mar-09-2010
75 Hospira Inc. II Feb-22-2010
76 Hospira Inc. II Feb-27-2007
77 ICU Medical, Inc. II Jan-09-2014
78 ICU Medical, Inc. II Jan-11-2012
79 ICU Medical, Inc. II Aug-16-2007
80 Medical Action Industries Inc I Mar-30-2010
81 Medical Product Specialist Inc dba MPS Acacia I Mar-30-2010
82 Medical Specialties Distributors, Inc. II Aug-09-2012
83 Medrad Inc II Dec-20-2012
84 Medtronic MiniMed I Jul-09-2013
85 Medtronic MiniMed I Jul-16-2009
86 Medtronic MiniMed Inc. II Dec-12-2014
87 Medtronic Minimed II Nov-17-2011
88 Merit Medical Systems, Inc. II Nov-21-2016
89 Merit Medical Systems, Inc. II Sep-11-2008
90 Navilyst Medical, Inc. II Jan-24-2014
91 RGI Medical Manufacturing, Inc. II Jul-07-2014
92 Roche Diagnostics Operations, Inc. II Dec-30-2014
93 Rymed Technologies, LLC II Jan-21-2016
94 Smiths Medical ASD, Inc. II May-27-2016
95 Smiths Medical ASD, Inc. II Mar-17-2015
96 Smiths Medical ASD, Inc. II Jan-17-2012
97 Smiths Medical Asd Inc II Jun-08-2015
98 Smiths Medical MD, Inc. II Apr-20-2009
99 Smiths Medical MD, Inc. II Feb-13-2008
100 Smiths Medical MD, Inc. II Aug-30-2007
101 US Infusion Inc dba Trucare Biomedix-USA II Mar-13-2015
102 Unomedical As II Nov-03-2016
103 Unomedical As II Jun-19-2015
104 WalkMed Infusion, LLC II Jul-18-2016
105 Zyno Medical LLC II Sep-27-2016

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