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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 5
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 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
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4364 4364
2020 3796 3796
2021 4673 4673
2022 4133 4138
2023 4431 4434
2024 968 968

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6877 6877
Break 2402 2402
Device Contamination with Chemical or Other Material 2297 2297
Retraction Problem 1632 1632
Fluid/Blood Leak 1051 1051
Deformation Due to Compressive Stress 806 806
Material Separation 800 800
Defective Component 697 697
Material Deformation 695 695
Material Puncture/Hole 538 541
Adverse Event Without Identified Device or Use Problem 536 536
Material Protrusion/Extrusion 488 488
Crack 418 418
Material Split, Cut or Torn 390 395
Detachment of Device or Device Component 371 371
Physical Resistance/Sticking 344 344
Unraveled Material 307 307
Packaging Problem 282 282
Material Twisted/Bent 280 280
Difficult or Delayed Activation 267 267
Material Frayed 238 238
Defective Device 222 222
Activation Problem 201 201
Difficult to Remove 198 198
Contamination 178 178
Device Markings/Labelling Problem 174 174
Obstruction of Flow 172 172
Fracture 165 165
Complete Blockage 149 149
Difficult to Insert 147 147
Component Missing 137 137
Loose or Intermittent Connection 119 119
Improper or Incorrect Procedure or Method 98 98
Difficult to Advance 95 95
Contamination /Decontamination Problem 94 94
Material Rupture 92 92
Product Quality Problem 92 92
Material Fragmentation 91 91
Device Damaged Prior to Use 91 91
Fail-Safe Problem 87 87
Delivered as Unsterile Product 87 87
Failure to Advance 83 83
Fitting Problem 78 78
Material Perforation 72 75
Insufficient Information 70 70
Infusion or Flow Problem 69 69
Dull, Blunt 62 62
Entrapment of Device 57 57
Material Integrity Problem 56 56
Unsealed Device Packaging 55 55
Protective Measures Problem 54 54
Separation Problem 51 51
Mechanical Problem 51 51
Fail-Safe Did Not Operate 45 45
Failure to Deliver 44 44
Improper Flow or Infusion 42 42
Free or Unrestricted Flow 39 39
Patient-Device Incompatibility 38 38
Disconnection 37 37
Device Dislodged or Dislocated 34 34
Air/Gas in Device 34 34
Tear, Rip or Hole in Device Packaging 33 33
Stretched 32 32
Backflow 32 32
Missing Information 31 31
Difficult or Delayed Separation 30 30
Use of Device Problem 29 29
Gas/Air Leak 29 29
Separation Failure 28 28
Material Discolored 28 28
Failure to Infuse 26 26
Difficult to Flush 25 25
Connection Problem 24 24
Activation, Positioning or Separation Problem 24 24
Output Problem 24 24
Patient Device Interaction Problem 23 23
Illegible Information 23 23
Biocompatibility 23 23
Therapeutic or Diagnostic Output Failure 21 21
Activation Failure 20 20
Wrong Label 20 20
Material Too Soft/Flexible 19 19
Mechanical Jam 19 19
Insufficient Flow or Under Infusion 19 19
Flushing Problem 19 19
Migration or Expulsion of Device 18 18
Material Too Rigid or Stiff 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Positioning Problem 18 18
Migration 18 18
Appropriate Term/Code Not Available 18 18
Fungus in Device Environment 17 17
Partial Blockage 14 14
Failure to Disconnect 13 13
Device Fell 13 13
Labelling, Instructions for Use or Training Problem 12 12
Burst Container or Vessel 11 11
Contamination of Device Ingredient or Reagent 11 11
Structural Problem 11 11
Suction Failure 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11269 11277
No Known Impact Or Consequence To Patient 4051 4051
No Consequences Or Impact To Patient 2536 2536
Insufficient Information 978 978
Foreign Body In Patient 774 774
No Patient Involvement 534 534
Pain 357 357
Needle Stick/Puncture 348 348
No Information 250 250
Device Embedded In Tissue or Plaque 160 160
Exposure to Body Fluids 160 160
Hemorrhage/Bleeding 153 153
No Code Available 152 152
Extravasation 136 136
Blood Loss 124 124
Phlebitis 110 110
Bacterial Infection 103 103
Hypersensitivity/Allergic reaction 95 95
Erythema 64 64
Hematoma 61 61
Unspecified Infection 61 61
Infiltration into Tissue 60 60
Thrombosis/Thrombus 58 58
Swelling/ Edema 55 55
Skin Inflammation/ Irritation 55 55
Bruise/Contusion 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Inflammation 46 46
Swelling 45 45
Discomfort 43 43
Perforation of Vessels 36 41
Anaphylactic Shock 30 30
Injury 28 28
Low Blood Pressure/ Hypotension 26 26
Thrombus 24 24
Failure of Implant 23 23
Abscess 20 20
Skin Inflammation 20 20
Death 19 19
Fever 19 19
Reaction 18 18
Rupture 16 16
Sepsis 15 15
Thrombosis 13 13
Laceration(s) 13 13
Chemical Exposure 13 13
Itching Sensation 12 12
Cardiac Arrest 11 11
Air Embolism 10 10
Tissue Damage 10 10
Rash 10 10
Foreign Body Embolism 9 9
Skin Discoloration 8 8
Abrasion 8 8
Necrosis 8 8
Tachycardia 7 7
Burning Sensation 7 7
Skin Tears 7 7
Patient Problem/Medical Problem 7 7
Numbness 6 6
Venipuncture 6 6
Anxiety 6 6
Skin Irritation 6 6
High Blood Pressure/ Hypertension 6 6
Hemostasis 6 6
Cellulitis 6 6
Edema 6 6
Hemolysis 5 5
Feeding Problem 5 5
Chills 5 5
Local Reaction 5 5
Obstruction/Occlusion 5 5
Reaction, Injection Site 5 5
Fluid Discharge 5 5
Embolism/Embolus 5 5
Radiation Exposure, Unintended 4 4
Unspecified Tissue Injury 4 4
Unintended Radiation Exposure 4 4
Underdose 4 4
Scar Tissue 4 4
Pneumothorax 4 4
Perforation 4 4
Vomiting 4 4
Emotional Changes 4 4
Bradycardia 4 4
Bronchitis 3 3
Arrhythmia 3 3
Vessel Or Plaque, Device Embedded In 3 3
Dyspnea 3 3
Infarction, Cerebral 3 3
Hypoglycemia 3 3
Fatigue 3 3
Weakness 3 3
Nausea 3 3
Chest Tightness/Pressure 3 3
Distress 3 3
Ulcer 3 3
Complaint, Ill-Defined 3 3
Reaction to Medicinal Component of Device 3 3
Tissue Breakdown 3 3

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. 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 B Braun Medical Inc II Oct-06-2022
14 Becton Dickinson & Company II Oct-19-2020
15 Becton Dickinson & Company II Jun-03-2019
16 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
17 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
18 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
19 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
20 Braxton Medical Corporation II Jan-27-2021
21 Cook Inc. II Mar-24-2020
22 Delta Med SpA II Aug-16-2021
23 Janus Trade Group II Nov-30-2020
24 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
25 Smiths Medical ASD Inc. II Nov-08-2019
26 Smiths Medical ASD Inc. II Apr-25-2019
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