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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, long-term greater than 30 days
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
ACCESS VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3085 3085
2022 2033 2033

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3757 3757
Break 1614 1614
Material Deformation 1156 1156
Leak/Splash 887 887
Fracture 766 766
Crack 561 561
Adverse Event Without Identified Device or Use Problem 500 500
Material Frayed 479 479
Component Incompatible 464 464
Material Separation 324 324
Defective Component 315 315
Detachment of Device or Device Component 313 313
Material Puncture/Hole 279 279
Failure to Infuse 265 265
Material Twisted/Bent 235 235
Material Rupture 221 221
Hole In Material 218 218
Device Dislodged or Dislocated 202 202
Material Split, Cut or Torn 174 174
Physical Resistance/Sticking 173 173
Obstruction of Flow 172 172
Detachment Of Device Component 145 145
Difficult to Remove 145 145
Device Operates Differently Than Expected 138 138
Contamination /Decontamination Problem 137 137
Kinked 121 121
Material Fragmentation 110 110
Backflow 107 107
Deformation Due to Compressive Stress 99 99
Migration or Expulsion of Device 98 98
Occlusion Within Device 96 96
Failure to Advance 95 95
Split 94 94
Malposition of Device 89 89
Burst Container or Vessel 89 89
Appropriate Term/Code Not Available 84 84
Data Problem 83 83
Unraveled Material 79 79
Stretched 76 76
Difficult to Insert 75 75
Material Integrity Problem 71 71
Difficult to Flush 70 70
Difficult to Advance 69 69
Device Contamination with Chemical or Other Material 67 67
Device Markings/Labelling Problem 65 65
Improper or Incorrect Procedure or Method 65 65
Entrapment of Device 64 64
Flushing Problem 63 63
Positioning Problem 62 62
Difficult or Delayed Separation 58 58
Expiration Date Error 57 57
Suction Problem 56 56
Complete Blockage 54 54
Defective Device 54 54
Migration 54 54
Physical Resistance 53 53
Component Missing 53 53
Disconnection 52 52
Insufficient Information 49 49
Loss of or Failure to Bond 46 46
Bent 44 44
Torn Material 44 44
Tear, Rip or Hole in Device Packaging 41 41
Infusion or Flow Problem 41 41
Material Protrusion/Extrusion 39 39
Fitting Problem 39 39
Connection Problem 38 38
Patient-Device Incompatibility 38 38
Aspiration Issue 38 38
Loose or Intermittent Connection 37 37
Mushroomed 34 34
Device Damaged Prior to Use 33 33
Unable to Obtain Readings 32 32
Misassembled 32 32
Nonstandard Device 31 31
Material Perforation 31 31
Therapeutic or Diagnostic Output Failure 31 31
Peeled/Delaminated 30 30
Sticking 28 28
Microbial Contamination of Device 27 27
Incorrect, Inadequate or Imprecise Resultor Readings 27 27
No Flow 27 27
No Apparent Adverse Event 26 26
Partial Blockage 26 26
Noise, Audible 22 22
Improper Flow or Infusion 21 21
Corroded 20 20
Knotted 20 20
Component Falling 19 19
Contamination 19 19
Material Discolored 18 18
No Display/Image 17 17
Unsealed Device Packaging 16 16
Use of Device Problem 16 16
Physical Property Issue 16 16
Activation, Positioning or SeparationProblem 15 15
Separation Failure 15 15
Restricted Flow rate 15 15
Air Leak 15 15
Product Quality Problem 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4348 4348
No Known Impact Or Consequence To Patient 3540 3540
No Consequences Or Impact To Patient 3345 3345
Foreign Body In Patient 468 468
No Code Available 451 451
No Information 337 337
No Patient Involvement 303 303
Insufficient Information 259 259
Pain 222 222
Device Embedded In Tissue or Plaque 171 171
Unspecified Infection 156 156
Swelling 139 139
Thrombus 120 120
Extravasation 107 107
Swelling/ Edema 68 68
Thrombosis/Thrombus 65 65
Infiltration into Tissue 65 65
Erythema 62 62
Thrombosis 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Bacterial Infection 55 55
Hemorrhage/Bleeding 50 50
Fever 42 42
Blood Loss 40 40
Discomfort 35 35
Injury 31 31
Reaction 29 29
Hypersensitivity/Allergic reaction 27 27
Death 24 24
Edema 23 23
Hematoma 23 23
Sepsis 22 22
Itching Sensation 21 21
Phlebitis 19 19
Rash 18 18
Failure of Implant 18 18
Dyspnea 18 18
Chest Pain 17 17
Burning Sensation 15 15
Inflammation 14 14
Tissue Damage 13 13
Pleural Effusion 12 12
Numbness 12 12
Cardiac Tamponade 11 11
Purulent Discharge 11 11
Bruise/Contusion 10 10
Embolism 9 9
Nausea 9 9
Discharge 9 9
Chemical Exposure 9 9
Patient Problem/Medical Problem 9 9
Anxiety 8 8
Perforation of Vessels 8 8
Tachycardia 8 8
Embolus 8 8
Cellulitis 8 8
Exposure to Body Fluids 7 7
Premature Labor 7 7
Fluid Discharge 6 6
Skin Inflammation/ Irritation 6 6
Arrhythmia 6 6
Vessel Or Plaque, Device Embedded In 6 6
Air Embolism 6 6
Cardiac Arrest 6 6
Laceration(s) 6 6
Venipuncture 6 6
Ventricular Tachycardia 6 6
Urticaria 6 6
Tingling 6 6
Chills 5 5
Pneumothorax 5 5
Local Reaction 5 5
Irritation 5 5
High Blood Pressure/ Hypertension 5 5
Pericardial Effusion 5 5
Thromboembolism 5 5
Needle Stick/Puncture 5 5
Alteration In Body Temperature 4 4
Embolism/Embolus 4 4
Foreign Body Embolism 4 4
Nerve Damage 4 4
Occlusion 4 4
Stroke/CVA 4 4
Respiratory Distress 4 4
Pneumonia 4 4
Perforation 4 4
Great Vessel Perforation 4 4
Hernia 3 3
Anaphylactoid 3 3
Fungal Infection 3 3
Staphylococcus Aureus 3 3
Septic Shock 3 3
Skin Discoloration 3 3
Skin Erosion 3 3
Skin Irritation 3 3
Pulmonary Embolism 3 3
Low Blood Pressure/ Hypotension 3 3
Abdominal Distention 3 3
Cardiac Perforation 3 3
Underdose 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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