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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
ACACIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRION CORP.
  SUBSTANTIALLY EQUIVALENT 3
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
BD
  SUBSTANTIALLY EQUIVALENT 4
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 3
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDIX
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 2
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC INC.
  SUBSTANTIALLY EQUIVALENT 3
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 1
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 9
IMED TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGYIN CAINA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PADI-LOCK, LLC
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 8
Q CORE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
RYMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 2
TEVA MEDICAL, LTD. (MIGADA PLANT)
  SUBSTANTIALLY EQUIVALENT 1
TOPSPINS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
WAI MEDICAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 10808
Leak / Splash 2607
Tube 2142
Disconnection 1922
Detachment of Device or device Component 1797
Break 1482
Material Separation 1241
Crack 1173
Failure To Adhere Or Bond 1067
Connector 948
Cannula 779
Device Operates Differently Than Expected 768
No Flow 718
Reflux within Device 661
Adhesive 617
Failure to Prime 572
Detachment Of Device Component 551
Material Deformation 516
Luer Valve 443
Air Eliminator 400
Infusion or Flow Problem 391
Bent 379
Material Twisted / Bent 369
Filter 341
Connection Problem 333
Adverse Event Without Identified Device or Use Problem 317
Valve 309
Hole In Material 306
Loss of or Failure to Bond 287
Occlusion Within Device 283
Insufficient Flow or Under Infusion 263
Kinked 247
Port 247
Improper Flow or Infusion 220
Device Contamination with Chemical or Other Material 201
Failure to Infuse 194
Pump 189
Partial Blockage 183
Filling Problem 181
Obstruction of Flow 181
Excess Flow or Over-Infusion 163
Device Alarm System 161
Y-Piece Connector 153
Material Fragmentation 141
Needle 137
Material Integrity Problem 135
Material Puncture / Hole 135
Cap 124
Sticking 121
Adapter (Adaptor) 120
Insufficient Information 119
Free or Unrestricted Flow 116
Physical Resistance / Sticking 115
Material Rupture 110
Loose or Intermittent Connection 108
Headset 106
System 105
Device Displays Incorrect Message 103
Cassette 102
Cut In Material 100
Device Dislodged or Dislocated 99
Device Component Or Accessory 99
Deformation Due to Compressive Stress 97
Component Missing 94
Backflow 93
Failure to Disconnect 91
Mechanical Problem 90
Improper or Incorrect Procedure or Method 90
Fracture 87
Fitting Problem 83
Protective Measures Problem 81
Appropriate Term/Code Not Available 68
Material Split, Cut or Torn 61
Clamp 60
Packaging Problem 59
Difficult or Delayed Activation 57
Defective Device 55
Device Operational Issue 52
Separation Failure 50
One-Way Valve 48
Stretched 46
Regulator 45
Product Quality Problem 43
Manufacturing, Packaging or Shipping Problem 43
Air Leak 41
T-Piece Connector 38
No Apparent Adverse Event 37
Tear, Rip or Hole in Device Packaging 37
Complete Blockage 34
Component(s), broken 34
Use of Device Problem 32
Migration or Expulsion of Device 31
Catheter 30
Failure to Reset 30
Failure to Advance 29
Activation Failure Including Expansion Failures 28
Contamination / decontamination Problem 27
Particulates 27
Device Slipped 27
Torn Material 27
Total Device Problems 41307

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Mar-29-2017
2 B Braun Medical Inc II May-23-2017
3 B. Braun Medical, Inc. II Jun-25-2018
4 B. Braun Medical, Inc. II Jul-09-2014
5 B. Braun Medical, Inc. II Feb-18-2014
6 Bard Access Systems II Jan-10-2017
7 Bard Access Systems II Apr-30-2015
8 Bard Access Systems II Mar-13-2015
9 Baxter Healthcare Corp II Oct-16-2015
10 Baxter Healthcare Corp II Sep-09-2014
11 Baxter Healthcare Corp. II Aug-29-2016
12 Baxter Healthcare Corp. II Jan-07-2016
13 Bayer Medical Care, Inc. II Oct-11-2018
14 Becton Dickinson & Company I Jul-11-2019
15 Becton Dickinson & Company I Jun-26-2019
16 Becton Dickinson & Company II Apr-10-2019
17 Becton Dickinson & Company II Nov-04-2018
18 Becton Dickinson & Company II May-01-2017
19 Becton Dickinson & Company II Mar-25-2015
20 Biomedix, Inc. II Oct-06-2014
21 CareFusion 303, Inc. II Nov-04-2018
22 CareFusion 303, Inc. II Jun-07-2018
23 CareFusion 303, Inc. II Aug-11-2017
24 CareFusion 303, Inc. II Apr-27-2017
25 CareFusion 303, Inc. II Feb-28-2017
26 CareFusion 303, Inc. II Feb-28-2017
27 CareFusion 303, Inc. II Mar-17-2016
28 CareFusion 303, Inc. II Dec-17-2015
29 CareFusion 303, Inc. II Nov-05-2015
30 CareFusion 303, Inc. II Feb-04-2015
31 CareFusion 303, Inc. II Jul-09-2014
32 CareFusion 303, Inc. II Apr-16-2014
33 CareFusion 303, Inc. II Feb-04-2014
34 CareFusion 303, Inc. II Feb-03-2014
35 Centurion Medical Products Corporation II Feb-23-2016
36 Churchill Medical Systems, Inc. II Apr-21-2015
37 Churchill Medical Systems, Inc. II Jan-23-2014
38 Codan Us Corporation II Jul-10-2014
39 ConMed Corporation II Feb-28-2018
40 Global Healthcare Inc II Feb-03-2016
41 Hospira Inc. II Jun-29-2016
42 Hospira Inc. II Mar-06-2014
43 ICU Medical, Inc. I Apr-15-2019
44 ICU Medical, Inc. II Jan-10-2017
45 ICU Medical, Inc. II Jan-09-2014
46 Medtronic Inc. II Jul-05-2018
47 Medtronic Inc. II Nov-18-2017
48 Medtronic MiniMed Inc. II Dec-12-2014
49 Merit Medical Systems, Inc. II Nov-21-2016
50 Navilyst Medical, Inc. II Jan-24-2014
51 RGI Medical Manufacturing, Inc. II Jul-07-2014
52 Repro-Med Systems, Inc. II Jan-05-2018
53 Roche Diagnostics Operations, Inc. II Dec-30-2014
54 Rymed Technologies, LLC II Jan-21-2016
55 Smiths Medical ASD Inc. II Oct-11-2018
56 Smiths Medical ASD Inc. II Jul-24-2017
57 Smiths Medical ASD Inc. II Mar-30-2017
58 Smiths Medical ASD, Inc. II May-27-2016
59 Smiths Medical ASD, Inc. II Mar-17-2015
60 Smiths Medical Asd Inc II Jun-08-2015
61 US Infusion Inc dba Trucare Biomedix-USA II Mar-13-2015
62 Unomedical As II Nov-03-2016
63 Unomedical As II Jun-19-2015
64 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
65 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-18-2017
66 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Dec-18-2016
67 Vygon U.S.A. II Apr-09-2019
68 WalkMed Infusion, LLC II Jul-18-2016
69 Zevex Incorporated (dba Moog Medical Medical Devices Group) II Feb-23-2018
70 Zyno Medical LLC II Jul-23-2019
71 Zyno Medical LLC II Sep-27-2016

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