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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
Regulation Description Intravascular catheter.
Product CodeFOZ
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 2
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
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
COOK ADVANCED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDIFIRST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS (INDIA) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE LABS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3298 3298
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 4431 4434
2024 4775 4777
2025 887 887

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 8175 8175
Break 3053 3053
Device Contamination with Chemical or Other Material 2688 2688
Retraction Problem 2478 2478
Fluid/Blood Leak 1818 1818
Material Separation 1031 1031
Defective Component 1025 1025
Material Deformation 833 833
Deformation Due to Compressive Stress 815 815
Material Puncture/Hole 741 744
Adverse Event Without Identified Device or Use Problem 623 623
Crack 621 621
Material Protrusion/Extrusion 604 604
Material Split, Cut or Torn 543 548
Material Twisted/Bent 526 526
Detachment of Device or Device Component 475 475
Physical Resistance/Sticking 426 426
Unraveled Material 384 384
Packaging Problem 341 341
Material Frayed 297 297
Difficult or Delayed Activation 286 286
Difficult to Remove 281 281
Contamination 271 271
Defective Device 269 269
Activation Problem 255 255
Difficult to Advance 231 231
Device Markings/Labelling Problem 224 224
Fracture 210 210
Obstruction of Flow 207 207
Difficult to Insert 200 200
Dull, Blunt 193 193
Component Missing 187 187
Complete Blockage 169 169
Contamination /Decontamination Problem 166 166
Loose or Intermittent Connection 153 153
Product Quality Problem 151 151
Fail-Safe Problem 141 141
Material Fragmentation 135 135
Improper or Incorrect Procedure or Method 127 127
Failure to Advance 127 127
Unsealed Device Packaging 125 125
Material Rupture 124 124
Device Damaged Prior to Use 118 118
Material Integrity Problem 111 111
Delivered as Unsterile Product 105 105
Material Perforation 101 104
Insufficient Information 97 97
Fitting Problem 85 85
Infusion or Flow Problem 82 82
Disconnection 81 81

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15081 15091
No Known Impact Or Consequence To Patient 5862 5862
No Consequences Or Impact To Patient 3271 3271
Insufficient Information 1365 1365
Foreign Body In Patient 1032 1032
No Patient Involvement 595 595
Pain 510 510
Needle Stick/Puncture 467 467
No Information 376 376
Device Embedded In Tissue or Plaque 250 250
No Code Available 232 232
Hemorrhage/Bleeding 201 201
Exposure to Body Fluids 189 189
Extravasation 175 175
Bacterial Infection 173 173
Blood Loss 149 149
Phlebitis 131 131
Unspecified Infection 121 121
Hypersensitivity/Allergic reaction 106 106
Discomfort 85 85
Infiltration into Tissue 84 84
Hematoma 78 78
Erythema 73 73
Skin Inflammation/ Irritation 71 71
Thrombosis/Thrombus 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 66 66
Swelling/ Edema 66 66
Swelling 64 64
Inflammation 59 59
Bruise/Contusion 57 57
Perforation of Vessels 56 61
Death 39 39
Injury 39 39
Low Blood Pressure/ Hypotension 38 38
Fever 38 38
Anaphylactic Shock 30 30
Thrombus 26 26
Abscess 23 23
Failure of Implant 23 23
Skin Inflammation 22 22
Sepsis 21 21
Reaction 20 20
Fluid Discharge 19 19
Chemical Exposure 19 19
Rupture 18 18
Thrombosis 18 18
Itching Sensation 16 16
Air Embolism 16 16
Laceration(s) 15 15
Tissue Damage 14 14

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 B Braun Medical Inc II Oct-06-2022
26 Becton Dickinson & Company II Oct-19-2020
27 Becton Dickinson & Company II Jun-03-2019
28 Becton Dickinson & Company II Nov-04-2018
29 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
30 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
31 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
32 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
33 Becton Dickinson Infusion Therapy Systems, Inc. II Jul-31-2024
34 Braxton Medical Corporation II Jan-27-2021
35 Cook Inc. II Mar-24-2020
36 Cook Inc. II Feb-15-2018
37 Delta Med SpA II Aug-16-2021
38 Janus Trade Group II Nov-30-2020
39 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
40 Smiths Medical ASD Inc. II Nov-08-2019
41 Smiths Medical ASD Inc. II Apr-25-2019
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