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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 3
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC
  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 LABS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  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 3295 3295
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4136 4141

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6302 6302
Device Contamination with Chemical or Other Material 2370 2370
Break 2264 2264
Retraction Problem 1212 1212
Fluid/Blood Leak 960 960
Material Separation 649 649
Material Deformation 630 630
Deformation Due to Compressive Stress 576 576
Adverse Event Without Identified Device or Use Problem 499 499
Material Protrusion/Extrusion 473 473
Detachment of Device or Device Component 389 389
Crack 377 377
Material Puncture/Hole 355 355
Defective Component 327 327
Physical Resistance/Sticking 285 285
Material Split, Cut or Torn 283 288
Packaging Problem 274 274
Unraveled Material 263 263
Difficult or Delayed Activation 213 213
Difficult to Remove 200 200
Material Twisted/Bent 196 196
Difficult to Advance 189 189
Defective Device 180 180
Dull, Blunt 179 179
Difficult to Insert 167 167
Device Markings/Labelling Problem 166 166
Material Frayed 165 165
Component Missing 149 149
Fracture 143 143
Obstruction of Flow 141 141
Complete Blockage 136 136
Contamination /Decontamination Problem 130 130
Activation Problem 120 120
Unsealed Device Packaging 110 110
Failure to Advance 110 110
Device Damaged Prior to Use 107 107
Loose or Intermittent Connection 107 107
Material Integrity Problem 103 103
Delivered as Unsterile Product 100 100
Material Fragmentation 99 99
Product Quality Problem 96 96
Contamination 93 93
Material Rupture 85 85
Improper or Incorrect Procedure or Method 78 78
Device Operates Differently Than Expected 78 78
Infusion or Flow Problem 77 77
Fail-Safe Problem 76 76
Entrapment of Device 72 72
Material Perforation 69 69
Insufficient Information 68 68
Nonstandard Device 67 67
Protective Measures Problem 66 66
Disconnection 62 62
Kinked 60 60
Detachment Of Device Component 60 60
Microbial Contamination of Device 59 59
Fitting Problem 58 58
Structural Problem 55 55
Mechanical Problem 53 53
Patient-Device Incompatibility 51 51
Fail-Safe Did Not Operate 49 49
Gas/Air Leak 45 45
Sticking 43 43
Appropriate Term/Code Not Available 43 43
Difficult To Position 41 41
Failure to Deliver 41 41
Difficult or Delayed Positioning 41 41
Tear, Rip or Hole in Device Packaging 40 40
Use of Device Problem 39 39
Free or Unrestricted Flow 37 37
Improper Flow or Infusion 36 36
Material Discolored 36 36
Device Dislodged or Dislocated 35 35
Separation Problem 35 35
Activation, Positioning or Separation Problem 33 33
Connection Problem 31 31
Manufacturing, Packaging or Shipping Problem 28 28
Degraded 27 27
Bent 27 27
Positioning Problem 26 26
Output Problem 25 25
Physical Resistance 25 25
Problem with Sterilization 24 24
Illegible Information 23 23
Missing Information 23 23
Difficult to Flush 23 23
Flushing Problem 22 22
Stretched 22 22
Backflow 22 22
Device Fell 22 22
Material Too Rigid or Stiff 22 22
Burst Container or Vessel 20 20
Air/Gas in Device 20 20
Failure to Infuse 20 20
Difficult or Delayed Separation 20 20
Therapeutic or Diagnostic Output Failure 20 20
Mechanical Jam 19 19
Occlusion Within Device 18 18
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Separation Failure 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7058 7063
No Known Impact Or Consequence To Patient 5862 5862
No Consequences Or Impact To Patient 3271 3271
No Patient Involvement 595 595
Foreign Body In Patient 591 591
Insufficient Information 502 502
No Information 376 376
Pain 328 328
Needle Stick/Puncture 307 307
No Code Available 231 231
Device Embedded In Tissue or Plaque 221 221
Bacterial Infection 167 167
Blood Loss 149 149
Exposure to Body Fluids 144 144
Extravasation 120 120
Hemorrhage/Bleeding 112 112
Unspecified Infection 101 101
Hypersensitivity/Allergic reaction 99 99
Phlebitis 89 89
Swelling 64 64
Infiltration into Tissue 64 64
Erythema 59 59
Hematoma 58 58
Bruise/Contusion 46 46
Thrombosis/Thrombus 43 43
Inflammation 39 39
Death 39 39
Injury 39 39
Discomfort 37 37
Fever 33 33
Swelling/ Edema 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Thrombus 26 26
Skin Inflammation 22 22
Anaphylactic Shock 22 22
Low Blood Pressure/ Hypotension 20 20
Perforation of Vessels 20 20
Sepsis 20 20
Reaction 20 20
Abscess 18 18
Thrombosis 18 18
Skin Inflammation/ Irritation 17 17
Tissue Damage 14 14
Itching Sensation 14 14
Patient Problem/Medical Problem 13 13
Chemical Exposure 13 13
Rupture 12 12
Skin Discoloration 11 11
Air Embolism 11 11
Rash 10 10
Laceration(s) 10 10
Cardiac Arrest 10 10
Cellulitis 9 9
Edema 9 9
Chills 9 9
Local Reaction 8 8
Necrosis 8 8
Distress 8 8
Numbness 8 8
Reaction, Injection Site 7 7
Skin Irritation 7 7
Complaint, Ill-Defined 7 7
Nausea 7 8
Abrasion 7 7
Venipuncture 6 6
Tachycardia 6 6
Hemostasis 6 6
Radiation Exposure, Unintended 6 6
High Blood Pressure/ Hypertension 6 6
Failure of Implant 5 5
Fatigue 5 5
Perforation 5 5
Respiratory Distress 5 5
Pneumonia 5 5
Weakness 5 5
Burning Sensation 5 5
Feeding Problem 5 5
Skin Tears 5 5
Loss of consciousness 5 5
Unintended Radiation Exposure 4 4
Fluid Discharge 4 4
Vomiting 4 4
Anxiety 4 4
Alteration In Body Temperature 4 4
Underdose 4 4
Vessel Or Plaque, Device Embedded In 4 4
Emotional Changes 4 4
Hepatitis 3 3
Ulcer 3 3
Staphylococcus Aureus 3 3
Tissue Breakdown 3 3
Bronchospasm 3 3
Chest Tightness/Pressure 3 3
Pneumothorax 3 3
Diarrhea 3 3
Dyspnea 3 4
Not Applicable 3 3
Hypoxia 3 3
Hyperemia 3 3
Bronchitis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Dec-10-2022
2 ARROW INTERNATIONAL Inc. II Jun-27-2022
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
4 Angiodynamics, Inc. II Jun-17-2020
5 Arrow International Inc II Feb-10-2021
6 Arrow International Inc II Jan-22-2020
7 Arrow International Inc II Oct-24-2019
8 Arrow International Inc II Oct-07-2019
9 Arrow International Inc II Nov-14-2018
10 Arrow International Inc II Oct-26-2018
11 Arrow International Inc II Aug-22-2018
12 Arrow International Inc II Aug-14-2018
13 Arrow International Inc II May-30-2018
14 Arrow International Inc II Apr-10-2018
15 Arrow International Inc II Mar-21-2018
16 Arrow International Inc II Mar-14-2018
17 Arrow International Inc II Mar-14-2018
18 Arrow International Inc II Mar-05-2018
19 Arrow International Inc II Feb-20-2018
20 B Braun Medical Inc II Oct-06-2022
21 Becton Dickinson & Company II Oct-19-2020
22 Becton Dickinson & Company II Jun-03-2019
23 Becton Dickinson & Company II Nov-04-2018
24 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
25 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
26 Braxton Medical Corporation II Jan-27-2021
27 Cook Inc. II Mar-24-2020
28 Cook Inc. II Feb-15-2018
29 Delta Med SpA II Aug-16-2021
30 Janus Trade Group II Nov-30-2020
31 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
32 Smiths Medical ASD Inc. II Nov-08-2019
33 Smiths Medical ASD Inc. II Apr-25-2019
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