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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
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
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 7258 7258
Break 2570 2570
Device Contamination with Chemical or Other Material 2379 2379
Retraction Problem 1820 1820
Fluid/Blood Leak 1267 1267
Material Separation 871 871
Defective Component 859 859
Deformation Due to Compressive Stress 813 813
Material Deformation 720 720
Material Puncture/Hole 621 624
Material Protrusion/Extrusion 553 553
Adverse Event Without Identified Device or Use Problem 550 550
Crack 478 478
Material Split, Cut or Torn 449 454
Detachment of Device or Device Component 380 380
Material Twisted/Bent 373 373
Physical Resistance/Sticking 362 362
Unraveled Material 326 326
Packaging Problem 293 293
Difficult or Delayed Activation 277 277
Material Frayed 269 269
Defective Device 237 237
Activation Problem 227 227
Difficult to Remove 207 207
Contamination 205 205
Device Markings/Labelling Problem 196 196
Obstruction of Flow 181 181
Fracture 174 174
Complete Blockage 158 158
Difficult to Insert 153 153
Component Missing 142 142
Loose or Intermittent Connection 123 123
Improper or Incorrect Procedure or Method 113 113
Difficult to Advance 111 111
Contamination /Decontamination Problem 102 102
Fail-Safe Problem 100 100
Material Rupture 98 98
Material Fragmentation 96 96
Product Quality Problem 95 95
Device Damaged Prior to Use 93 93
Delivered as Unsterile Product 87 87
Failure to Advance 84 84
Fitting Problem 78 78
Material Perforation 76 79
Insufficient Information 74 74
Infusion or Flow Problem 71 71
Dull, Blunt 65 65
Entrapment of Device 57 57
Unsealed Device Packaging 57 57
Material Integrity Problem 57 57

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12918 12926
No Known Impact Or Consequence To Patient 4051 4051
No Consequences Or Impact To Patient 2536 2536
Insufficient Information 1166 1166
Foreign Body In Patient 882 882
No Patient Involvement 534 534
Needle Stick/Puncture 381 381
Pain 380 380
No Information 250 250
Device Embedded In Tissue or Plaque 171 171
Exposure to Body Fluids 171 171
Hemorrhage/Bleeding 167 167
No Code Available 152 152
Extravasation 142 142
Blood Loss 124 124
Phlebitis 120 120
Bacterial Infection 104 104
Hypersensitivity/Allergic reaction 96 96
Infiltration into Tissue 67 67
Erythema 66 66
Hematoma 63 63
Skin Inflammation/ Irritation 62 62
Unspecified Infection 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Thrombosis/Thrombus 61 61
Swelling/ Edema 59 59
Discomfort 54 54
Bruise/Contusion 50 50
Inflammation 49 49
Swelling 45 45
Perforation of Vessels 37 42
Low Blood Pressure/ Hypotension 31 31
Anaphylactic Shock 30 30
Injury 28 28
Thrombus 24 24
Failure of Implant 23 23
Skin Inflammation 20 20
Abscess 20 20
Death 19 19
Fever 19 19
Reaction 18 18
Rupture 16 16
Sepsis 15 15
Laceration(s) 14 14
Thrombosis 13 13
Chemical Exposure 13 13
Itching Sensation 12 12
Air Embolism 12 12
Cardiac Arrest 11 11
Foreign Body Embolism 10 10

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. II Jun-17-2020
9 Arrow International Inc II Feb-10-2021
10 Arrow International Inc II Jan-22-2020
11 Arrow International Inc II Oct-24-2019
12 Arrow International Inc II Oct-07-2019
13 B Braun Medical Inc II Oct-06-2022
14 Becton Dickinson & Company II Oct-19-2020
15 Becton Dickinson & Company II Jun-03-2019
16 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
17 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
18 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
19 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
20 Becton Dickinson Infusion Therapy Systems, Inc. II Jul-31-2024
21 Braxton Medical Corporation II Jan-27-2021
22 Cook Inc. II Mar-24-2020
23 Delta Med SpA II Aug-16-2021
24 Janus Trade Group II Nov-30-2020
25 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
26 Smiths Medical ASD Inc. II Nov-08-2019
27 Smiths Medical ASD Inc. II Apr-25-2019
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