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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 3
B.BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 4
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
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 2
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 2
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3297 3297
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 2967 2967

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6848 6848
Break 2540 2540
Device Contamination with Chemical or Other Material 2427 2427
Retraction Problem 1639 1639
Fluid/Blood Leak 1100 1100
Material Separation 800 800
Deformation Due to Compressive Stress 738 738
Material Deformation 707 707
Adverse Event Without Identified Device or Use Problem 555 555
Defective Component 551 551
Material Protrusion/Extrusion 485 485
Material Puncture/Hole 473 473
Crack 437 437
Detachment of Device or Device Component 430 430
Material Split, Cut or Torn 354 359
Physical Resistance/Sticking 343 343
Unraveled Material 306 306
Packaging Problem 299 299
Material Twisted/Bent 245 245
Difficult or Delayed Activation 244 244
Difficult to Remove 227 227
Defective Device 223 223
Difficult to Advance 199 199
Material Frayed 197 197
Difficult to Insert 186 186
Dull, Blunt 185 185
Device Markings/Labelling Problem 182 182
Obstruction of Flow 175 175
Component Missing 175 175
Contamination 166 166
Fracture 163 163
Activation Problem 163 163
Complete Blockage 145 145
Contamination /Decontamination Problem 133 133
Loose or Intermittent Connection 130 130
Failure to Advance 117 117
Product Quality Problem 117 117
Unsealed Device Packaging 115 115
Device Damaged Prior to Use 113 113
Material Fragmentation 110 110
Material Integrity Problem 106 106
Delivered as Unsterile Product 102 102
Fail-Safe Problem 98 98
Material Rupture 96 96
Improper or Incorrect Procedure or Method 89 89
Material Perforation 82 82
Entrapment of Device 79 79
Infusion or Flow Problem 78 78
Device Operates Differently Than Expected 78 78
Insufficient Information 75 75
Fitting Problem 71 71
Mechanical Problem 69 69
Protective Measures Problem 69 69
Nonstandard Device 67 67
Disconnection 66 66
Detachment Of Device Component 60 60
Kinked 60 60
Microbial Contamination of Device 59 59
Structural Problem 55 55
Fail-Safe Did Not Operate 53 53
Patient-Device Incompatibility 51 51
Gas/Air Leak 50 50
Separation Problem 45 45
Appropriate Term/Code Not Available 45 45
Difficult or Delayed Positioning 44 44
Tear, Rip or Hole in Device Packaging 43 43
Failure to Deliver 43 43
Sticking 43 43
Improper Flow or Infusion 43 43
Device Dislodged or Dislocated 41 41
Difficult To Position 41 41
Use of Device Problem 41 41
Material Discolored 38 38
Free or Unrestricted Flow 38 38
Activation, Positioning or Separation Problem 34 34
Connection Problem 34 34
Manufacturing, Packaging or Shipping Problem 29 29
Backflow 29 29
Difficult to Flush 29 29
Separation Failure 29 29
Stretched 28 28
Degraded 28 28
Bent 27 27
Positioning Problem 27 27
Difficult or Delayed Separation 27 27
Air/Gas in Device 27 27
Missing Information 26 26
Output Problem 26 26
Physical Resistance 25 25
Material Too Rigid or Stiff 25 25
Problem with Sterilization 24 24
Failure to Infuse 24 24
Illegible Information 23 23
Device Fell 22 22
Biocompatibility 22 22
Flushing Problem 22 22
Burst Container or Vessel 21 21
Therapeutic or Diagnostic Output Failure 21 21
Patient Device Interaction Problem 21 21
Mechanical Jam 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9352 9357
No Known Impact Or Consequence To Patient 5862 5862
No Consequences Or Impact To Patient 3271 3271
Foreign Body In Patient 741 741
Insufficient Information 709 709
No Patient Involvement 595 595
Pain 405 405
No Information 376 376
Needle Stick/Puncture 363 363
No Code Available 231 231
Device Embedded In Tissue or Plaque 228 228
Bacterial Infection 172 172
Exposure to Body Fluids 167 167
Blood Loss 149 149
Hemorrhage/Bleeding 148 148
Extravasation 136 136
Phlebitis 111 111
Unspecified Infection 105 105
Hypersensitivity/Allergic reaction 100 100
Infiltration into Tissue 70 70
Erythema 65 65
Swelling 64 64
Hematoma 63 63
Discomfort 54 54
Bruise/Contusion 53 53
Thrombosis/Thrombus 53 53
Swelling/ Edema 49 49
Inflammation 49 49
Death 39 39
Injury 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Fever 38 38
Perforation of Vessels 35 40
Skin Inflammation/ Irritation 33 33
Anaphylactic Shock 28 28
Low Blood Pressure/ Hypotension 26 26
Thrombus 26 26
Skin Inflammation 22 22
Abscess 21 21
Reaction 20 20
Sepsis 20 20
Failure of Implant 19 19
Thrombosis 18 18
Rupture 15 15
Itching Sensation 15 15
Tissue Damage 14 14
Laceration(s) 13 13
Chemical Exposure 13 13
Patient Problem/Medical Problem 13 13
Cardiac Arrest 12 12
Air Embolism 11 11
Skin Discoloration 11 11
Rash 10 10
Chills 9 9
Cellulitis 9 9
Edema 9 9
Necrosis 9 9
Numbness 8 8
Distress 8 8
Local Reaction 8 8
Skin Tears 8 8
Skin Irritation 7 7
Reaction, Injection Site 7 7
Complaint, Ill-Defined 7 7
Burning Sensation 7 7
Nausea 7 8
Abrasion 7 7
High Blood Pressure/ Hypertension 6 6
Hemostasis 6 6
Venipuncture 6 6
Tachycardia 6 6
Radiation Exposure, Unintended 6 6
Fluid Discharge 5 5
Vomiting 5 5
Weakness 5 5
Respiratory Distress 5 5
Pneumonia 5 5
Perforation 5 5
Loss of consciousness 5 5
Obstruction/Occlusion 5 5
Hemolysis 5 5
Fatigue 5 5
Feeding Problem 5 5
Dyspnea 4 5
Vessel Or Plaque, Device Embedded In 4 4
Bradycardia 4 4
Emotional Changes 4 4
Anxiety 4 4
Alteration In Body Temperature 4 4
Underdose 4 4
Embolism/Embolus 4 4
Unintended Radiation Exposure 4 4
Reaction to Medicinal Component of Device 3 3
Foreign Body Embolism 3 3
Bronchospasm 3 3
Tissue Breakdown 3 3
Not Applicable 3 3
Ulcer 3 3
Chest Tightness/Pressure 3 3
Pneumothorax 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Jun-21-2023
2 ARROW INTERNATIONAL Inc. I Dec-10-2022
3 ARROW INTERNATIONAL Inc. II Jun-27-2022
4 Access Vascular, Inc II Feb-22-2023
5 Access Vascular, Inc II Feb-22-2023
6 Access Vascular, Inc II Feb-10-2023
7 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
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 Arrow International Inc II Nov-14-2018
14 Arrow International Inc II Oct-26-2018
15 Arrow International Inc II Aug-22-2018
16 Arrow International Inc II Aug-14-2018
17 Arrow International Inc II May-30-2018
18 Arrow International Inc II Apr-10-2018
19 Arrow International Inc II Mar-21-2018
20 Arrow International Inc II Mar-14-2018
21 Arrow International Inc II Mar-14-2018
22 Arrow International Inc II Mar-05-2018
23 Arrow International Inc II Feb-20-2018
24 B Braun Medical Inc II Oct-06-2022
25 Becton Dickinson & Company II Oct-19-2020
26 Becton Dickinson & Company II Jun-03-2019
27 Becton Dickinson & Company II Nov-04-2018
28 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
29 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
30 Braxton Medical Corporation II Jan-27-2021
31 Cook Inc. II Mar-24-2020
32 Cook Inc. II Feb-15-2018
33 Delta Med SpA II Aug-16-2021
34 Janus Trade Group II Nov-30-2020
35 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
36 Smiths Medical ASD Inc. II Nov-08-2019
37 Smiths Medical ASD Inc. II Apr-25-2019
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