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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 3
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 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 1964 1964
2018 3297 3297
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 4431 4434
2024 1302 1302

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7645 7645
Break 3499 3499
Device Contamination with Chemical or Other Material 2710 2710
Retraction Problem 2188 2188
Fluid/Blood Leak 1610 1610
Material Separation 1060 1060
Deformation Due to Compressive Stress 817 817
Material Deformation 815 815
Defective Component 755 755
Adverse Event Without Identified Device or Use Problem 699 699
Crack 631 631
Material Puncture/Hole 583 586
Unraveled Material 556 556
Kinked 546 546
Material Protrusion/Extrusion 516 516
Detachment of Device or Device Component 503 503
Material Split, Cut or Torn 419 424
Physical Resistance/Sticking 389 389
Difficult to Remove 367 367
Material Twisted/Bent 335 335
Packaging Problem 319 319
Physical Resistance 308 308
Device Operates Differently Than Expected 302 302
Material Frayed 295 295
Detachment Of Device Component 287 287
Difficult or Delayed Activation 274 274
Fracture 257 257
Defective Device 256 256
Difficult to Advance 249 249
Component Missing 239 239
Difficult to Insert 224 224
Activation Problem 212 212
Device Markings/Labelling Problem 211 211
Obstruction of Flow 203 203
Contamination 201 201
Failure to Advance 197 197
Dull, Blunt 192 192
Material Fragmentation 188 188
Insufficient Information 178 178
Loose or Intermittent Connection 167 167
Complete Blockage 158 158
Unsealed Device Packaging 157 157
Product Quality Problem 155 155
Material Integrity Problem 152 152
Fail-Safe Problem 152 152
Device Damaged Prior to Use 149 149
Contamination /Decontamination Problem 148 148
Material Rupture 141 141
Activation, Positioning or Separation Problem 130 130
Improper or Incorrect Procedure or Method 129 129
Bent 125 125
Delivered as Unsterile Product 111 111
Entrapment of Device 109 109
Sticking 108 108
Protective Measures Problem 103 103
Disconnection 101 101
Use of Device Problem 100 100
Fitting Problem 95 95
Hole In Material 95 95
Material Perforation 90 93
Infusion or Flow Problem 88 88
Mechanical Problem 84 84
Device Dislodged or Dislocated 75 75
Occlusion Within Device 73 73
Patient-Device Incompatibility 72 72
Stretched 68 68
Nonstandard Device 68 68
Migration or Expulsion of Device 66 66
Appropriate Term/Code Not Available 64 64
Split 61 61
Structural Problem 61 61
Microbial Contamination of Device 59 59
Device Or Device Fragments Location Unknown 57 57
Connection Problem 57 57
Improper Flow or Infusion 56 56
Separation Problem 56 56
Positioning Failure 56 56
Tear, Rip or Hole in Device Packaging 54 54
Fail-Safe Did Not Operate 53 53
Gas/Air Leak 52 52
Separation Failure 49 49
Difficult or Delayed Positioning 47 47
Material Discolored 47 47
Failure to Deliver 45 45
Difficult or Delayed Separation 44 44
Difficult To Position 43 43
Fail-Safe Design Failure 42 42
Device Packaging Compromised 42 42
Free or Unrestricted Flow 41 41
Positioning Problem 38 38
Difficult to Flush 38 38
Backflow 36 36
Manufacturing, Packaging or Shipping Problem 36 36
Air/Gas in Device 34 34
Missing Information 32 32
Partial Blockage 32 32
Flushing Problem 31 31
Burst Container or Vessel 28 28
Degraded 28 28
Failure to Infuse 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11532 11540
No Known Impact Or Consequence To Patient 7313 7313
No Consequences Or Impact To Patient 4637 4637
Foreign Body In Patient 1035 1035
Insufficient Information 1009 1009
No Patient Involvement 704 704
Needle Stick/Puncture 649 649
No Information 623 623
Pain 504 504
No Code Available 481 481
Device Embedded In Tissue or Plaque 431 431
Exposure to Body Fluids 215 215
Blood Loss 212 212
Hemorrhage/Bleeding 186 186
Bacterial Infection 179 179
Phlebitis 169 169
Extravasation 162 162
Unspecified Infection 141 141
Swelling 116 116
Hypersensitivity/Allergic reaction 108 108
Erythema 96 96
Hematoma 88 88
Infiltration into Tissue 88 88
Discomfort 72 72
Death 66 66
Inflammation 64 64
Thrombosis/Thrombus 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Bruise/Contusion 56 56
Swelling/ Edema 55 55
Skin Inflammation/ Irritation 55 55
Injury 55 55
Fever 46 46
Anaphylactic Shock 40 40
Abscess 40 40
Perforation of Vessels 39 44
Thrombus 36 36
Tissue Damage 34 34
Reaction 34 34
Low Blood Pressure/ Hypotension 32 32
Sepsis 31 31
Thrombosis 29 29
Failure of Implant 25 25
Skin Inflammation 24 24
Chemical Exposure 20 20
Itching Sensation 20 20
Necrosis 18 18
Skin Discoloration 18 18
Rupture 18 18
Edema 18 18
Laceration(s) 17 17
Complaint, Ill-Defined 17 17
Rash 16 16
Air Embolism 16 16
Cardiac Arrest 16 16
Pneumothorax 15 15
Venipuncture 14 14
Burning Sensation 14 14
Test Result 14 14
Patient Problem/Medical Problem 13 13
Vessel Or Plaque, Device Embedded In 12 12
Cellulitis 11 11
Skin Irritation 11 11
Surgical procedure, additional 11 11
Skin Tears 11 11
Numbness 10 10
Tachycardia 10 10
Chills 10 10
Vomiting 9 9
Anxiety 9 9
Distress 9 9
Nausea 9 10
Purulent Discharge 9 9
Dyspnea 9 10
Abrasion 9 9
Foreign Body Embolism 9 9
Reaction, Injection Site 8 8
Local Reaction 8 8
Respiratory Distress 8 8
Pleural Effusion 7 7
Pneumonia 7 7
Hemolysis 7 7
High Blood Pressure/ Hypertension 7 7
Obstruction/Occlusion 7 7
Loss of consciousness 6 6
Underdose 6 6
Radiation Exposure, Unintended 6 6
Tissue Breakdown 6 6
Hemostasis 6 6
Hypoglycemia 6 6
Burn(s) 6 6
Perforation 6 6
Staphylococcus Aureus 6 6
Other (for use when an appropriate patient code cannot be identified) 6 6
Ulcer 5 5
Weakness 5 5
Stroke/CVA 5 5
Hepatitis 5 5
Embolism 5 5
Fatigue 5 5

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 Medical Systems I Feb-02-2010
53 Braxton Medical Corporation II Jan-27-2021
54 Centurion Medical Products Corporation I Dec-02-2016
55 Cook Inc. II Mar-24-2020
56 Cook Inc. II Feb-15-2018
57 Cook Inc. II Dec-12-2016
58 Cook, Inc. I Feb-23-2011
59 Delta Med SpA II Aug-16-2021
60 Janus Trade Group II Nov-30-2020
61 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
62 Nipro Medical Corporation III Jan-06-2016
63 Nipro Medical Corporation II Jun-19-2014
64 Smiths Medical ASD Inc. II Nov-08-2019
65 Smiths Medical ASD Inc. II Apr-25-2019
66 Smiths Medical ASD Inc. II Dec-19-2016
67 Terumo Medical Corporation II May-01-2017
68 Tri-State Hospital Supply Corporation I Mar-25-2009
69 Vygon Corporation II Oct-22-2014
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