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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 4774 4776
2025 406 406

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 8086 8086
Break 3034 3034
Device Contamination with Chemical or Other Material 2679 2679
Retraction Problem 2326 2326
Fluid/Blood Leak 1764 1764
Material Separation 1022 1022
Defective Component 1006 1006
Material Deformation 824 824
Deformation Due to Compressive Stress 815 815
Material Puncture/Hole 732 735
Adverse Event Without Identified Device or Use Problem 622 622
Crack 609 609
Material Protrusion/Extrusion 592 592
Material Split, Cut or Torn 538 543
Material Twisted/Bent 512 512
Detachment of Device or Device Component 472 472
Physical Resistance/Sticking 423 423
Unraveled Material 382 382
Packaging Problem 339 339
Material Frayed 297 297
Difficult or Delayed Activation 286 286
Difficult to Remove 279 279
Contamination 267 267
Defective Device 264 264
Activation Problem 252 252
Difficult to Advance 231 231
Device Markings/Labelling Problem 223 223
Fracture 209 209
Obstruction of Flow 206 206
Difficult to Insert 198 198
Dull, Blunt 192 192
Component Missing 187 187
Complete Blockage 168 168
Contamination /Decontamination Problem 165 165
Loose or Intermittent Connection 153 153
Product Quality Problem 151 151
Fail-Safe Problem 139 139
Material Fragmentation 135 135
Failure to Advance 127 127
Improper or Incorrect Procedure or Method 126 126
Unsealed Device Packaging 125 125
Material Rupture 122 122
Device Damaged Prior to Use 118 118
Material Integrity Problem 111 111
Delivered as Unsterile Product 105 105
Material Perforation 100 103
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 14679 14689
No Known Impact Or Consequence To Patient 5862 5862
No Consequences Or Impact To Patient 3271 3271
Insufficient Information 1324 1324
Foreign Body In Patient 1020 1020
No Patient Involvement 595 595
Pain 506 506
Needle Stick/Puncture 458 458
No Information 376 376
Device Embedded In Tissue or Plaque 250 250
No Code Available 232 232
Hemorrhage/Bleeding 198 198
Exposure to Body Fluids 187 187
Extravasation 175 175
Bacterial Infection 173 173
Blood Loss 149 149
Phlebitis 131 131
Unspecified Infection 121 121
Hypersensitivity/Allergic reaction 106 106
Discomfort 84 84
Infiltration into Tissue 83 83
Hematoma 77 77
Erythema 73 73
Skin Inflammation/ Irritation 71 71
Swelling/ Edema 66 66
Thrombosis/Thrombus 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 64 64
Swelling 64 64
Inflammation 59 59
Perforation of Vessels 54 59
Bruise/Contusion 53 53
Death 39 39
Injury 39 39
Fever 38 38
Low Blood Pressure/ Hypotension 38 38
Anaphylactic Shock 30 30
Thrombus 26 26
Failure of Implant 23 23
Abscess 23 23
Skin Inflammation 22 22
Sepsis 21 21
Reaction 20 20
Chemical Exposure 19 19
Thrombosis 18 18
Rupture 18 18
Itching Sensation 16 16
Air Embolism 16 16
Fluid Discharge 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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