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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
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BD
  SUBSTANTIALLY EQUIVALENT 9
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 9
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DELTA MED SPA
  SUBSTANTIALLY EQUIVALENT 2
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS GROUP PLC
  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 1604 1604

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4876 4876
Device Contamination with Chemical or Other Material 1978 1978
Break 1852 1852
Retraction Problem 942 942
Fluid Leak 810 810
Material Deformation 449 449
Material Separation 440 440
Material Protrusion/Extrusion 385 385
Adverse Event Without Identified Device or Use Problem 342 342
Kinked 321 321
Crack 315 315
Unraveled Material 287 287
Device Operates Differently Than Expected 267 267
Detachment of Device or Device Component 250 250
Packaging Problem 203 203
Detachment Of Device Component 203 203
Difficult to Remove 199 199
Physical Resistance 199 199
Physical Resistance/Sticking 170 170
Difficult to Advance 166 166
Difficult or Delayed Activation 156 156
Dull, Blunt 152 152
Deformation Due to Compressive Stress 152 152
Failure to Advance 133 133
Device Markings/Labelling Problem 126 126
Unsealed Device Packaging 126 126
Component Missing 120 120
Contamination /Decontamination Problem 120 120
Device Damaged Prior to Use 119 119
Material Integrity Problem 119 119
Fracture 119 119
Material Twisted/Bent 118 118
Material Puncture/Hole 116 116
Difficult to Insert 116 116
Complete Blockage 111 111
Material Fragmentation 110 110
Material Split, Cut or Torn 108 108
Bent 98 98
Defective Component 97 97
Insufficient Information 95 95
Protective Measures Problem 92 92
Material Frayed 92 92
Fail-Safe Problem 90 90
Obstruction of Flow 87 87
Material Rupture 86 86
Delivered as Unsterile Product 84 84
Hole In Material 77 77
Product Quality Problem 76 76
Loose or Intermittent Connection 75 75
Sticking 75 75
Disconnection 74 74
Entrapment of Device 71 71
Defective Device 71 71
Nonstandard Device 67 67
Infusion or Flow Problem 62 62
Microbial Contamination of Device 59 59
Structural Problem 58 58
Occlusion Within Device 58 58
Patient-Device Incompatibility 57 57
Use of Device Problem 56 56
Activation Problem 55 55
Appropriate Term/Code Not Available 49 49
Activation, Positioning or SeparationProblem 45 45
Mechanical Problem 44 44
Improper or Incorrect Procedure or Method 44 44
Difficult To Position 42 42
Device Dislodged or Dislocated 40 40
Difficult or Delayed Positioning 40 40
Fail-Safe Design Failure 38 38
Fail-Safe Did Not Operate 38 38
Device Packaging Compromised 38 38
Split 37 37
Gas Leak 35 35
Connection Problem 34 34
Migration or Expulsion of Device 32 32
Fitting Problem 31 31
Material Discolored 31 31
Manufacturing, Packaging or Shipping Problem 31 31
Partial Blockage 28 28
Flushing Problem 26 26
Positioning Problem 25 25
Problem with Sterilization 24 24
Device Or Device Fragments Location Unknown 23 23
Tear, Rip or Hole in Device Packaging 23 23
Contamination 22 22
Device Fell 21 21
Improper Flow or Infusion 21 21
Device Slipped 20 20
Difficult to Flush 19 19
Burst Container or Vessel 19 19
Degraded 19 19
Free or Unrestricted Flow 19 19
Component Falling 19 19
Malposition of Device 19 19
Peeled/Delaminated 18 18
Device Disinfection Or Sterilization Issue 18 18
Therapeutic or Diagnostic Output Failure 18 18
Torn Material 17 17
Air Leak 17 17
Material Perforation 17 17

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 1142 1142
No Patient Involvement 667 667
No Information 518 518
No Code Available 433 433
Foreign Body In Patient 363 363
Needle Stick/Puncture 332 332
Device Embedded In Tissue or Plaque 300 300
Pain 222 222
Blood Loss 195 195
Exposure to Body Fluids 130 130
Unspecified Infection 105 105
Insufficient Information 97 97
Swelling 96 96
Bacterial Infection 82 82
Extravasation 74 74
Infiltration into Tissue 59 59
Death 57 57
Hemorrhage/Bleeding 56 56
Phlebitis 54 54
Erythema 53 53
Injury 52 52
Hypersensitivity/Allergic reaction 46 46
Hematoma 43 43
Discomfort 40 40
Fever 37 37
Thrombus 33 33
Bruise/Contusion 32 32
Inflammation 31 31
Thrombosis 27 27
Skin Inflammation 24 24
Reaction 24 24
Tissue Damage 22 22
Sepsis 21 21
Abscess 19 19
Low Blood Pressure/ Hypotension 17 17
Chemical Exposure 16 16
Anaphylactic Shock 14 14
Edema 14 14
Complaint, Ill-Defined 13 13
Patient Problem/Medical Problem 13 13
Itching Sensation 12 12
Vessel Or Plaque, Device Embedded In 10 10
Skin Discoloration 10 10
Skin Irritation 10 10
Chills 9 9
Air Embolism 9 9
Cellulitis 9 9
Venipuncture 9 9
Burning Sensation 9 9
Necrosis 9 9
Cardiac Arrest 8 8
Rash 8 8
Numbness 8 8
Reaction, Injection Site 7 7
Nausea 7 8
Local Reaction 7 7
Respiratory Distress 7 7
Vomiting 7 7
Tachycardia 6 6
Pneumonia 6 6
Hemostasis 6 6
Radiation Exposure, Unintended 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 6 6
Staphylococcus Aureus 5 5
Ulcer 5 5
Loss of consciousness 5 5
Underdose 5 5
Feeding Problem 5 5
Dyspnea 5 6
Alteration In Body Temperature 5 5
Distress 5 5
Laceration(s) 5 5
Stroke/CVA 5 5
Pneumothorax 5 5
Pleural Effusion 5 5
Weakness 5 5
Purulent Discharge 4 4
Hyperemia 4 4
Tissue Breakdown 4 4
Fatigue 4 4
Hepatitis 4 4
High Blood Pressure/ Hypertension 4 4
Skin Tears 4 4
Fluid Discharge 3 3
Unintended Radiation Exposure 3 3
Perforation 3 3
Emotional Changes 3 3
Pressure Sores 3 3
Ulceration 3 3
Chest Tightness/Pressure 3 3
Test Result 3 3
Not Applicable 3 3
Hypoglycemia 3 3
Embolus 3 3
Infarction, Cerebral 3 3
Bronchitis 3 3
Abdominal Pain 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 Janus Trade Group II Nov-30-2020
32 Nipro Medical Corporation III Jan-06-2016
33 Smiths Medical ASD Inc. II Nov-08-2019
34 Smiths Medical ASD Inc. II Apr-25-2019
35 Smiths Medical ASD Inc. II Dec-19-2016
36 Terumo Medical Corporation II May-01-2017
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