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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
Product CodeFOZ
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMECO MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATION, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL ( A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
B. BRAUN MELSUNGEN AG
  SUBSTANTIALLY EQUIVALENT 1
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MELSUNGEN AG
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 2
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY (BD)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 7
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 6
BECTON, DICKINSON AND COMPANY (BARD ACCESS SYSTEMS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
C.R.BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK ADVANCED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 2
DELTA MED SRL
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FLEXICATH LTD.
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI SANXIN MEDTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JMS NORTH AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KOFU FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 2
LUTHER NEEDLESAFE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFIRST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS (INDIA) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE LABS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
POLY MEDICURE LIMITED
  SUBSTANTIALLY EQUIVALENT 3
SAUDI MAIS CO. FOR MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKYDANCE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 2
TANGENT MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO (PHILIPPINES) CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
U.S. SAFETY SYRINGES CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
UNOMEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR PATHWAYS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VYGON
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YOMURA TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 812 813
2015 729 729
2016 926 926
2017 1965 1965
2018 3298 3298
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 4431 4434
2024 3022 3022

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7967 7967
Break 3630 3630
Device Contamination with Chemical or Other Material 2773 2773
Retraction Problem 2346 2346
Fluid/Blood Leak 1790 1790
Material Separation 1118 1118
Defective Component 899 899
Material Deformation 836 836
Deformation Due to Compressive Stress 823 823
Adverse Event Without Identified Device or Use Problem 712 712
Crack 687 687
Material Puncture/Hole 658 661
Material Protrusion/Extrusion 574 574
Unraveled Material 571 571
Kinked 546 546
Detachment of Device or Device Component 511 511
Material Split, Cut or Torn 475 480
Material Twisted/Bent 417 417
Physical Resistance/Sticking 407 407
Difficult to Remove 375 375
Packaging Problem 327 327
Material Frayed 316 316
Physical Resistance 308 308
Device Operates Differently Than Expected 302 302
Detachment Of Device Component 287 287
Difficult or Delayed Activation 283 283
Defective Device 265 265
Difficult to Advance 264 264
Fracture 264 264
Component Missing 242 242
Activation Problem 231 231
Difficult to Insert 230 230
Contamination 228 228
Device Markings/Labelling Problem 223 223
Obstruction of Flow 208 208
Failure to Advance 197 197
Dull, Blunt 195 195
Material Fragmentation 193 193
Insufficient Information 181 181
Loose or Intermittent Connection 171 171
Fail-Safe Problem 165 165
Complete Blockage 165 165
Unsealed Device Packaging 159 159
Product Quality Problem 157 157
Contamination /Decontamination Problem 156 156
Material Integrity Problem 152 152
Device Damaged Prior to Use 151 151
Material Rupture 147 147
Improper or Incorrect Procedure or Method 143 143
Activation, Positioning or Separation Problem 130 130

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12920 12928
No Known Impact Or Consequence To Patient 7314 7314
No Consequences Or Impact To Patient 4637 4637
Insufficient Information 1167 1167
Foreign Body In Patient 1124 1124
No Patient Involvement 704 704
Needle Stick/Puncture 676 676
No Information 623 623
Pain 524 524
No Code Available 482 482
Device Embedded In Tissue or Plaque 439 439
Exposure to Body Fluids 224 224
Blood Loss 212 212
Hemorrhage/Bleeding 196 196
Bacterial Infection 179 179
Phlebitis 174 174
Extravasation 168 168
Unspecified Infection 142 142
Swelling 116 116
Hypersensitivity/Allergic reaction 109 109
Erythema 97 97
Infiltration into Tissue 95 95
Hematoma 90 90
Discomfort 83 83
Death 66 66
Inflammation 66 66
Skin Inflammation/ Irritation 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Thrombosis/Thrombus 61 61
Swelling/ Edema 59 59
Bruise/Contusion 56 56
Injury 55 55
Fever 46 46
Abscess 40 40
Anaphylactic Shock 40 40
Perforation of Vessels 40 45
Low Blood Pressure/ Hypotension 36 36
Thrombus 36 36
Reaction 34 34
Tissue Damage 34 34
Sepsis 31 31
Thrombosis 29 29
Failure of Implant 25 25
Skin Inflammation 24 24
Chemical Exposure 20 20
Itching Sensation 20 20
Skin Discoloration 19 19
Air Embolism 18 18
Necrosis 18 18
Laceration(s) 18 18

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Oct-05-2023
2 ARROW INTERNATIONAL Inc. I Jun-21-2023
3 ARROW INTERNATIONAL Inc. I Dec-10-2022
4 ARROW INTERNATIONAL Inc. II Jun-27-2022
5 Access Vascular, Inc II Feb-22-2023
6 Access Vascular, Inc II Feb-22-2023
7 Access Vascular, Inc II Feb-10-2023
8 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
9 Angiodynamics, Inc. II Jun-17-2020
10 Arrow International Inc II Feb-10-2021
11 Arrow International Inc II Jan-22-2020
12 Arrow International Inc II Oct-24-2019
13 Arrow International Inc II Oct-07-2019
14 Arrow International Inc II Nov-14-2018
15 Arrow International Inc II Oct-26-2018
16 Arrow International Inc II Aug-22-2018
17 Arrow International Inc II Aug-14-2018
18 Arrow International Inc II May-30-2018
19 Arrow International Inc II Apr-10-2018
20 Arrow International Inc II Mar-21-2018
21 Arrow International Inc II Mar-14-2018
22 Arrow International Inc II Mar-14-2018
23 Arrow International Inc II Mar-05-2018
24 Arrow International Inc II Feb-20-2018
25 Arrow International Inc II Jun-12-2017
26 Arrow International Inc II Jun-06-2017
27 Arrow International Inc II Apr-10-2017
28 Arrow International Inc II Jul-06-2016
29 Arrow International Inc II Sep-30-2015
30 Arrow International Inc II Feb-10-2015
31 Arrow International Inc II Jan-22-2015
32 Arrow International Inc II May-19-2014
33 Arrow International Inc II Apr-24-2014
34 Arrow International Inc I Jun-26-2012
35 Arrow International Inc II Jun-19-2012
36 Arrow International Inc II Sep-25-2010
37 Arrow International Inc I Mar-05-2010
38 Arrow International Inc II Aug-10-2009
39 Arrow International Inc II Jun-24-2009
40 B Braun Medical Inc II Oct-06-2022
41 Bard Access Systems II Mar-13-2015
42 Bard Access Systems II Jan-23-2014
43 Becton Dickinson & Company II Oct-19-2020
44 Becton Dickinson & Company II Jun-03-2019
45 Becton Dickinson & Company II Nov-04-2018
46 Becton Dickinson & Company II May-18-2016
47 Becton Dickinson & Company II Dec-12-2014
48 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
49 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
50 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
51 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
52 Becton Dickinson Infusion Therapy Systems, Inc. II Jul-31-2024
53 Becton Dickinson Medical Systems I Feb-02-2010
54 Braxton Medical Corporation II Jan-27-2021
55 Centurion Medical Products Corporation I Dec-02-2016
56 Cook Inc. II Mar-24-2020
57 Cook Inc. II Feb-15-2018
58 Cook Inc. II Dec-12-2016
59 Cook, Inc. I Feb-23-2011
60 Delta Med SpA II Aug-16-2021
61 Janus Trade Group II Nov-30-2020
62 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
63 Nipro Medical Corporation III Jan-06-2016
64 Nipro Medical Corporation II Jun-19-2014
65 Smiths Medical ASD Inc. II Nov-08-2019
66 Smiths Medical ASD Inc. II Apr-25-2019
67 Smiths Medical ASD Inc. II Dec-19-2016
68 Terumo Medical Corporation II May-01-2017
69 Tri-State Hospital Supply Corporation I Mar-25-2009
70 Vygon Corporation II Oct-22-2014
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