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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 2
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
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
COOK ADVANCED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIFIRST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS (INDIA) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE LABS
  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 3
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
VENOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 4431 4434
2024 4775 4777
2025 2297 2297

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6347 6347
Retraction Problem 2376 2376
Break 2304 2304
Device Contamination with Chemical or Other Material 1722 1722
Fluid/Blood Leak 1566 1566
Defective Component 1080 1080
Material Separation 857 857
Deformation Due to Compressive Stress 806 806
Material Puncture/Hole 704 707
Material Deformation 676 676
Material Twisted/Bent 518 518
Adverse Event Without Identified Device or Use Problem 515 515
Material Split, Cut or Torn 511 516
Crack 495 495
Material Protrusion/Extrusion 425 425
Physical Resistance/Sticking 330 330
Unraveled Material 307 307
Detachment of Device or Device Component 304 304
Contamination 274 274
Material Frayed 270 270
Activation Problem 255 255
Packaging Problem 252 252
Defective Device 220 220
Difficult or Delayed Activation 220 220
Difficult to Remove 189 189
Device Markings/Labelling Problem 166 166
Obstruction of Flow 160 160
Fracture 159 159
Difficult to Insert 145 145
Complete Blockage 124 124
Fail-Safe Problem 117 117
Improper or Incorrect Procedure or Method 116 116
Component Missing 114 114
Loose or Intermittent Connection 107 107
Material Rupture 105 105
Difficult to Advance 100 100
Material Perforation 95 98
Product Quality Problem 87 87
Fitting Problem 79 79
Material Fragmentation 77 77
Device Damaged Prior to Use 77 77
Material Integrity Problem 71 71
Insufficient Information 70 70
Contamination /Decontamination Problem 68 68
Separation Problem 66 66
Difficult or Delayed Separation 64 64
Failure to Advance 62 62
Separation Failure 61 61
Delivered as Unsterile Product 56 56
Connection Problem 54 54

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16240 16250
No Consequences Or Impact To Patient 2109 2109
Insufficient Information 1511 1511
No Known Impact Or Consequence To Patient 1025 1025
Foreign Body In Patient 929 929
No Patient Involvement 423 423
Pain 402 402
Needle Stick/Puncture 366 366
Hemorrhage/Bleeding 169 169
Extravasation 149 149
Exposure to Body Fluids 145 145
Phlebitis 110 110
Device Embedded In Tissue or Plaque 109 109
Bacterial Infection 102 102
Hypersensitivity/Allergic reaction 85 85
Skin Inflammation/ Irritation 74 74
Hematoma 69 69
Swelling/ Edema 69 69
No Code Available 68 68
Thrombosis/Thrombus 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 67 67
Perforation of Vessels 65 70
Discomfort 64 64
Unspecified Infection 59 59
Infiltration into Tissue 54 54
Bruise/Contusion 53 53
Blood Loss 51 51
Erythema 49 49
Inflammation 49 49
No Information 37 37
Low Blood Pressure/ Hypotension 36 36
Anaphylactic Shock 30 30
Failure of Implant 23 23
Thrombus 22 22
Fluid Discharge 18 18
Swelling 16 16
Abscess 16 16
Rupture 15 15
Skin Inflammation 15 15
Fever 15 15
Injury 14 14
Laceration(s) 14 14
Sepsis 14 14
Chemical Exposure 13 13
Death 12 12
Air Embolism 11 11
Foreign Body Embolism 10 10
Reaction 8 8
Hemolysis 8 8
Rash 8 8

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 B Braun Medical Inc II Mar-19-2025
12 B Braun Medical Inc II Oct-06-2022
13 Becton Dickinson & Company II Oct-19-2020
14 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
15 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
16 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
17 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
18 Becton Dickinson Infusion Therapy Systems, Inc. II Jun-23-2025
19 Becton Dickinson Infusion Therapy Systems, Inc. II May-21-2025
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
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