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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, long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&Z US, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDCOMP (MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC (DBA MEDCOMP_
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2099 2099
2018 2321 2321
2019 2051 2051
2020 2539 2539
2021 3079 3079

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 2856 2856
Break 1456 1456
Material Deformation 891 891
Leak/Splash 864 864
Fracture 659 659
Crack 530 530
Adverse Event Without Identified Device or Use Problem 426 426
Material Frayed 394 394
Component Incompatible 330 330
Material Separation 286 286
Detachment of Device or Device Component 285 285
Defective Component 271 271
Material Puncture/Hole 260 260
Material Rupture 218 218
Hole In Material 218 218
Material Twisted/Bent 203 203
Failure to Infuse 198 198
Device Dislodged or Dislocated 178 178
Material Split, Cut or Torn 157 157
Obstruction of Flow 153 153
Physical Resistance/Sticking 145 145
Detachment Of Device Component 145 145
Device Operates Differently Than Expected 138 138
Difficult to Remove 136 136
Kinked 121 121
Contamination /Decontamination Problem 106 106
Material Fragmentation 100 100
Occlusion Within Device 96 96
Split 94 94
Migration or Expulsion of Device 93 93
Failure to Advance 89 89
Malposition of Device 86 86
Appropriate Term/Code Not Available 83 83
Backflow 82 82
Unraveled Material 77 77
Burst Container or Vessel 76 76
Deformation Due to Compressive Stress 76 76
Material Integrity Problem 70 70
Difficult to Insert 70 70
Data Problem 68 68
Device Contamination with Chemical or Other Material 67 67
Flushing Problem 63 63
Stretched 61 61
Positioning Problem 61 61
Difficult to Flush 60 60
Entrapment of Device 58 58
Expiration Date Error 57 57
Device Markings/Labelling Problem 55 55
Difficult to Advance 54 54
Improper or Incorrect Procedure or Method 54 54
Complete Blockage 53 53
Physical Resistance 53 53
Disconnection 51 51
Component Missing 50 50
Defective Device 49 49
Insufficient Information 49 49
Migration 46 46
Suction Problem 46 46
Bent 44 44
Torn Material 44 44
Loss of or Failure to Bond 40 40
Fitting Problem 39 39
Aspiration Issue 38 38
Infusion or Flow Problem 38 38
Patient-Device Incompatibility 37 37
Tear, Rip or Hole in Device Packaging 37 37
Loose or Intermittent Connection 37 37
Connection Problem 35 35
Difficult or Delayed Separation 35 35
Mushroomed 34 34
Device Damaged Prior to Use 32 32
Material Perforation 31 31
Nonstandard Device 31 31
Material Protrusion/Extrusion 30 30
Therapeutic or Diagnostic Output Failure 28 28
Sticking 28 28
No Flow 27 27
Microbial Contamination of Device 27 27
Partial Blockage 26 26
Peeled/Delaminated 22 22
Incorrect, Inadequate or Imprecise Resultor Readings 22 22
Unable to Obtain Readings 21 21
Improper Flow or Infusion 21 21
No Apparent Adverse Event 21 21
Corroded 20 20
Knotted 20 20
Component Falling 19 19
Noise, Audible 19 19
Material Discolored 18 18
Contamination 17 17
Misassembled 17 17
No Display/Image 16 16
Unsealed Device Packaging 16 16
Physical Property Issue 16 16
Air Leak 15 15
Use of Device Problem 14 14
Unintended Movement 14 14
Separation Problem 14 14
Device Sensing Problem 14 14
Activation, Positioning or SeparationProblem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3540 3540
No Consequences Or Impact To Patient 3345 3345
No Clinical Signs, Symptoms or Conditions 2629 2629
No Code Available 451 451
Foreign Body In Patient 401 401
No Information 337 337
No Patient Involvement 303 303
Pain 196 196
Insufficient Information 162 162
Device Embedded In Tissue or Plaque 161 161
Unspecified Infection 144 144
Swelling 139 139
Thrombus 120 120
Extravasation 88 88
Thrombosis 59 59
Infiltration into Tissue 53 53
Bacterial Infection 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Erythema 46 46
Thrombosis/Thrombus 41 41
Blood Loss 40 40
Hemorrhage/Bleeding 39 39
Fever 38 38
Swelling/ Edema 35 35
Discomfort 34 34
Injury 31 31
Reaction 29 29
Death 24 24
Edema 23 23
Hypersensitivity/Allergic reaction 23 23
Sepsis 22 22
Itching Sensation 21 21
Hematoma 18 18
Rash 18 18
Phlebitis 17 17
Chest Pain 16 16
Dyspnea 15 15
Burning Sensation 15 15
Tissue Damage 13 13
Inflammation 13 13
Numbness 12 12
Cardiac Tamponade 11 11
Pleural Effusion 11 11
Failure of Implant 10 10
Nausea 9 9
Embolism 9 9
Purulent Discharge 9 9
Discharge 9 9
Patient Problem/Medical Problem 9 9
Chemical Exposure 9 9
Cellulitis 8 8
Embolus 8 8
Exposure to Body Fluids 7 7
Bruise/Contusion 7 7
Anxiety 7 7
Premature Labor 7 7
Perforation of Vessels 7 7
Tachycardia 7 7
Venipuncture 6 6
Tingling 6 6
Ventricular Tachycardia 6 6
Vessel Or Plaque, Device Embedded In 6 6
Cardiac Arrest 6 6
Irritation 5 5
Urticaria 5 5
Chills 5 5
Thromboembolism 5 5
Needle Stick/Puncture 5 5
Pericardial Effusion 5 5
Fluid Discharge 5 5
Alteration In Body Temperature 4 4
Great Vessel Perforation 4 4
Respiratory Distress 4 4
Laceration(s) 4 4
Pneumonia 4 4
Pneumothorax 4 4
Occlusion 4 4
High Blood Pressure/ Hypertension 4 4
Stroke/CVA 4 4
Air Embolism 4 4
Arrhythmia 4 4
Pulmonary Embolism 3 3
Low Blood Pressure/ Hypotension 3 3
Nerve Damage 3 3
Staphylococcus Aureus 3 3
Perforation 3 3
Skin Erosion 3 3
Skin Irritation 3 3
Hernia 3 3
Abdominal Distention 3 3
Cardiac Perforation 3 3
Embolism/Embolus 3 3
Foreign Body Embolism 3 3
Skin Inflammation/ Irritation 3 3
Radiation Exposure, Unintended 2 2
Underdose 2 2
Electric Shock 2 2
Lethargy 2 2
Chest Tightness/Pressure 2 2
Complaint, Ill-Defined 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-14-2017
4 Angiodynamics, Inc. II Jun-17-2020
5 Arrow International Inc II Feb-14-2020
6 Arrow International Inc II Jun-16-2019
7 Arrow International Inc II May-16-2019
8 Arrow International Inc II Sep-19-2018
9 Arrow International Inc II Jul-08-2018
10 Arrow International Inc II May-30-2018
11 Arrow International Inc II Apr-10-2018
12 Arrow International Inc II Mar-14-2018
13 Arrow International Inc II Feb-22-2018
14 Arrow International Inc II Feb-13-2018
15 Arrow International Inc II Nov-28-2017
16 Arrow International Inc II Jun-27-2017
17 Arrow International Inc II Jun-12-2017
18 Arrow International Inc II Mar-08-2017
19 Arrow International Inc II Feb-22-2017
20 Bard Access Systems Inc. II Jul-01-2021
21 Bard Access Systems Inc. II Jun-30-2021
22 Bard Access Systems Inc. II May-20-2021
23 Bard Access Systems Inc. II Feb-06-2018
24 Becton Dickinson & Company II May-21-2020
25 Medical Components, Inc dba MedComp II Oct-25-2019
26 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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