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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
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
B.BRAUN MELSUNGEN AG
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
C.R.BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDIFIRST CO., LTD.
  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 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TANGENT MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 926 926
2017 1964 1964
2018 3295 3295
2019 4364 4364
2020 3797 3797
2021 3588 3588

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5521 5521
Device Contamination with Chemical or Other Material 2242 2242
Break 2102 2102
Retraction Problem 1065 1065
Fluid Leak 930 930
Material Deformation 502 502
Material Separation 500 500
Adverse Event Without Identified Device or Use Problem 465 465
Material Protrusion/Extrusion 427 427
Crack 335 335
Kinked 321 321
Unraveled Material 308 308
Detachment of Device or Device Component 273 273
Device Operates Differently Than Expected 267 267
Deformation Due to Compressive Stress 230 230
Packaging Problem 228 228
Difficult to Remove 208 208
Detachment Of Device Component 203 203
Physical Resistance 199 199
Difficult or Delayed Activation 187 187
Physical Resistance/Sticking 184 184
Difficult to Advance 166 166
Dull, Blunt 163 163
Material Puncture/Hole 148 148
Device Markings/Labelling Problem 148 148
Failure to Advance 138 138
Component Missing 137 137
Material Twisted/Bent 129 129
Fracture 128 128
Unsealed Device Packaging 128 128
Complete Blockage 124 124
Device Damaged Prior to Use 121 121
Contamination /Decontamination Problem 121 121
Material Integrity Problem 120 120
Material Split, Cut or Torn 119 119
Difficult to Insert 118 118
Material Fragmentation 117 117
Defective Component 117 117
Material Frayed 110 110
Insufficient Information 100 100
Bent 98 98
Obstruction of Flow 97 97
Protective Measures Problem 94 94
Fail-Safe Problem 92 92
Material Rupture 90 90
Delivered as Unsterile Product 88 88
Loose or Intermittent Connection 79 79
Entrapment of Device 78 78
Hole In Material 77 77
Product Quality Problem 77 77
Defective Device 76 76
Sticking 75 75
Disconnection 75 75
Infusion or Flow Problem 71 71
Activation Problem 68 68
Nonstandard Device 67 67
Improper or Incorrect Procedure or Method 63 63
Patient-Device Incompatibility 62 62
Use of Device Problem 61 61
Microbial Contamination of Device 59 59
Structural Problem 58 58
Occlusion Within Device 58 58
Appropriate Term/Code Not Available 51 51
Device Dislodged or Dislocated 48 48
Mechanical Problem 46 46
Activation, Positioning or SeparationProblem 45 45
Difficult To Position 42 42
Difficult or Delayed Positioning 41 41
Fail-Safe Design Failure 38 38
Device Packaging Compromised 38 38
Connection Problem 38 38
Gas Leak 38 38
Fail-Safe Did Not Operate 38 38
Split 37 37
Material Discolored 36 36
Migration or Expulsion of Device 32 32
Fitting Problem 32 32
Manufacturing, Packaging or Shipping Problem 32 32
Improper Flow or Infusion 31 31
Failure to Deliver 30 30
Partial Blockage 29 29
Free or Unrestricted Flow 29 29
Tear, Rip or Hole in Device Packaging 28 28
Flushing Problem 27 27
Contamination 26 26
Positioning Problem 25 25
Problem with Sterilization 24 24
Device Or Device Fragments Location Unknown 23 23
Material Perforation 22 22
Difficult to Flush 21 21
Device Fell 21 21
Therapeutic or Diagnostic Output Failure 20 20
Device Slipped 20 20
Separation Failure 19 19
Degraded 19 19
Burst Container or Vessel 19 19
Component Falling 19 19
Malposition of Device 19 19
Device Disinfection Or Sterilization Issue 18 18
Peeled/Delaminated 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7046 7046
No Consequences Or Impact To Patient 4044 4044
No Clinical Signs, Symptoms or Conditions 2787 2787
No Patient Involvement 667 667
No Information 518 518
No Code Available 433 433
Foreign Body In Patient 419 419
Needle Stick/Puncture 371 371
Device Embedded In Tissue or Plaque 304 304
Pain 253 253
Insufficient Information 252 252
Blood Loss 195 195
Exposure to Body Fluids 153 153
Bacterial Infection 138 138
Unspecified Infection 105 105
Swelling 96 96
Hypersensitivity/Allergic reaction 86 86
Extravasation 82 82
Hemorrhage/Bleeding 66 66
Phlebitis 66 66
Infiltration into Tissue 62 62
Death 57 57
Erythema 55 55
Injury 52 52
Hematoma 45 45
Discomfort 41 41
Inflammation 38 38
Fever 37 37
Thrombus 33 33
Bruise/Contusion 33 33
Thrombosis 27 27
Skin Inflammation 24 24
Reaction 24 24
Sepsis 23 23
Tissue Damage 22 22
Thrombosis/Thrombus 20 20
Abscess 19 19
Low Blood Pressure/ Hypotension 18 18
Anaphylactic Shock 17 17
Chemical Exposure 16 16
Itching Sensation 15 15
Edema 14 14
Complaint, Ill-Defined 13 13
Patient Problem/Medical Problem 13 13
Cardiac Arrest 11 11
Rash 11 11
Vessel Or Plaque, Device Embedded In 10 10
Skin Discoloration 10 10
Skin Irritation 10 10
Chills 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Numbness 9 9
Air Embolism 9 9
Cellulitis 9 9
Venipuncture 9 9
Burning Sensation 9 9
Necrosis 9 9
Nausea 8 9
Local Reaction 8 8
Respiratory Distress 7 7
Vomiting 7 7
Swelling/ Edema 7 7
Reaction, Injection Site 7 7
Loss of consciousness 6 6
Rupture 6 6
Radiation Exposure, Unintended 6 6
Distress 6 6
Tachycardia 6 6
Pneumonia 6 6
Pneumothorax 6 6
Hemostasis 6 6
Laceration(s) 5 5
Stroke/CVA 5 5
Pleural Effusion 5 5
Weakness 5 5
Alteration In Body Temperature 5 5
Staphylococcus Aureus 5 5
Ulcer 5 5
Underdose 5 5
Dyspnea 5 6
High Blood Pressure/ Hypertension 5 5
Hepatitis 5 5
Feeding Problem 5 5
Fatigue 4 4
Perforation 4 4
Emotional Changes 4 4
Skin Tears 4 4
Unintended Radiation Exposure 4 4
Tissue Breakdown 4 4
Purulent Discharge 4 4
Hyperemia 4 4
Hypoglycemia 3 3
Embolus 3 3
Infarction, Cerebral 3 3
Diarrhea 3 3
Bronchitis 3 3
Abdominal Pain 3 3
Anxiety 3 3
Therapeutic Response, Decreased 3 3
Chest Tightness/Pressure 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
2 Angiodynamics, Inc. II Jun-17-2020
3 Arrow International Inc II Feb-10-2021
4 Arrow International Inc II Jan-22-2020
5 Arrow International Inc II Oct-24-2019
6 Arrow International Inc II Oct-07-2019
7 Arrow International Inc II Nov-14-2018
8 Arrow International Inc II Oct-26-2018
9 Arrow International Inc II Aug-22-2018
10 Arrow International Inc II Aug-14-2018
11 Arrow International Inc II May-30-2018
12 Arrow International Inc II Apr-10-2018
13 Arrow International Inc II Mar-21-2018
14 Arrow International Inc II Mar-14-2018
15 Arrow International Inc II Mar-14-2018
16 Arrow International Inc II Mar-05-2018
17 Arrow International Inc II Feb-20-2018
18 Arrow International Inc II Jun-12-2017
19 Arrow International Inc II Jun-06-2017
20 Arrow International Inc II Apr-10-2017
21 Arrow International Inc II Jul-06-2016
22 Becton Dickinson & Company II Oct-19-2020
23 Becton Dickinson & Company II Jun-03-2019
24 Becton Dickinson & Company II Nov-04-2018
25 Becton Dickinson & Company II May-18-2016
26 Braxton Medical Corporation II Jan-27-2021
27 Centurion Medical Products Corporation I Dec-02-2016
28 Cook Inc. II Mar-24-2020
29 Cook Inc. II Feb-15-2018
30 Cook Inc. II Dec-12-2016
31 Delta Med SpA II Aug-16-2021
32 Janus Trade Group II Nov-30-2020
33 Nipro Medical Corporation III Jan-06-2016
34 Smiths Medical ASD Inc. II Nov-08-2019
35 Smiths Medical ASD Inc. II Apr-25-2019
36 Smiths Medical ASD Inc. II Dec-19-2016
37 Terumo Medical Corporation II May-01-2017
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