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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
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 1
C.R. BARD, INC (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2321 2321
2019 2051 2051
2020 2539 2539
2021 3085 3085
2022 3264 3264

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3929 3929
Break 1388 1388
Material Deformation 1212 1212
Adverse Event Without Identified Device or Use Problem 739 739
Fracture 729 729
Leak/Splash 648 648
Material Frayed 498 498
Component Incompatible 484 484
Crack 465 465
Defective Component 331 331
Detachment of Device or Device Component 310 310
Material Separation 303 303
Material Puncture/Hole 292 292
Failure to Infuse 289 289
Material Twisted/Bent 235 235
Device Dislodged or Dislocated 197 197
Material Split, Cut or Torn 180 180
Obstruction of Flow 179 179
Physical Resistance/Sticking 177 177
Material Rupture 154 154
Contamination /Decontamination Problem 146 146
Deformation Due to Compressive Stress 103 103
Difficult to Remove 101 101
Backflow 100 100
Data Problem 99 99
Material Fragmentation 88 88
Burst Container or Vessel 85 85
Stretched 82 82
Appropriate Term/Code Not Available 78 78
Failure to Advance 78 78
Hole In Material 77 77
Migration or Expulsion of Device 75 75
Malposition of Device 68 68
Device Markings/Labelling Problem 66 66
Difficult to Insert 66 66
Suction Problem 65 65
Difficult or Delayed Separation 63 63
Difficult to Flush 60 60
Difficult to Advance 60 60
Migration 58 58
Expiration Date Error 57 57
Improper or Incorrect Procedure or Method 54 54
Positioning Problem 53 53
Loss of or Failure to Bond 53 53
Unraveled Material 52 52
Complete Blockage 52 52
Device Operates Differently Than Expected 52 52
Defective Device 50 50
Component Missing 49 49
Kinked 49 49
Entrapment of Device 45 45
Material Integrity Problem 45 45
Device Contamination with Chemical or Other Material 45 45
Detachment Of Device Component 44 44
Tear, Rip or Hole in Device Packaging 40 40
Flushing Problem 39 39
Material Protrusion/Extrusion 38 38
Infusion or Flow Problem 37 37
Fitting Problem 36 36
Insufficient Information 36 36
Disconnection 36 36
Unable to Obtain Readings 35 35
Misassembled 34 34
Mushroomed 33 33
Therapeutic or Diagnostic Output Failure 32 32
Nonstandard Device 32 32
No Apparent Adverse Event 29 29
Patient-Device Incompatibility 28 28
Corroded 27 27
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Loose or Intermittent Connection 27 27
Device Damaged Prior to Use 26 26
Peeled/Delaminated 24 24
Physical Resistance 24 24
Connection Problem 23 23
No Flow 22 22
Material Perforation 21 21
Occlusion Within Device 20 20
Improper Flow or Infusion 19 19
Split 19 19
Torn Material 19 19
No Display/Image 17 17
Material Discolored 16 16
Expulsion 15 15
Noise, Audible 15 15
Separation Problem 15 15
Output Problem 15 15
Restricted Flow rate 14 14
Unsealed Device Packaging 14 14
Bent 14 14
Contamination 14 14
Device Sensing Problem 14 14
Unintended Movement 14 14
Product Quality Problem 13 13
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Coagulation in Device or Device Ingredient 13 13
Activation, Positioning or Separation Problem 13 13
Gas/Air Leak 12 12
Partial Blockage 12 12
Aspiration Issue 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4960 4960
No Consequences Or Impact To Patient 3124 3124
No Known Impact Or Consequence To Patient 2325 2325
Foreign Body In Patient 475 475
Swelling/ Edema 454 454
Erythema 437 437
Insufficient Information 378 378
No Code Available 251 251
No Patient Involvement 232 232
Pain 202 202
No Information 196 196
Unspecified Infection 148 148
Device Embedded In Tissue or Plaque 136 136
Thrombus 116 116
Swelling 98 98
Extravasation 88 88
Thrombosis/Thrombus 76 76
Infiltration into Tissue 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Thrombosis 50 50
Hemorrhage/Bleeding 49 49
Fever 40 40
Bacterial Infection 39 39
Discomfort 28 28
Injury 27 27
Blood Loss 27 27
Failure of Implant 24 24
Sepsis 22 22
Reaction 22 22
Death 20 20
Hypersensitivity/Allergic reaction 20 20
Hematoma 19 19
Rash 19 19
Chest Pain 18 18
Edema 18 18
Phlebitis 18 18
Itching Sensation 17 17
Dyspnea 14 14
Inflammation 12 12
Pleural Effusion 12 12
Burning Sensation 11 11
Purulent Discharge 11 11
Needle Stick/Puncture 11 11
Cardiac Tamponade 11 11
Chemical Exposure 11 11
Tissue Damage 10 10
Arrhythmia 10 10
Bruise/Contusion 10 10
Laceration(s) 10 10
Embolism 8 8
Embolus 8 8
Tachycardia 8 8
Perforation of Vessels 8 8
Numbness 8 8
Cellulitis 8 8
Skin Inflammation/ Irritation 8 8
Patient Problem/Medical Problem 7 7
Fluid Discharge 7 7
Discharge 7 7
Exposure to Body Fluids 7 7
Anxiety 7 7
Premature Labor 7 7
Urticaria 6 6
Air Embolism 6 6
Local Reaction 6 6
Nausea 6 6
Tingling 6 6
Foreign Body Reaction 5 5
Thromboembolism 5 5
Chills 5 5
Irritation 5 5
Pericardial Effusion 5 5
Fungal Infection 5 5
Pneumothorax 5 5
Cardiac Arrest 5 5
Respiratory Distress 4 4
Perforation 4 4
Foreign Body Embolism 4 4
Occlusion 4 4
Skin Erosion 4 4
Embolism/Embolus 4 4
Great Vessel Perforation 4 4
Stroke/CVA 3 3
Anaphylactoid 3 3
Ventricular Tachycardia 3 3
Septic Shock 3 3
Low Blood Pressure/ Hypotension 3 3
Pulmonary Embolism 3 3
Abdominal Distention 3 3
Vessel Or Plaque, Device Embedded In 3 3
High Blood Pressure/ Hypertension 3 3
Hernia 3 3
Scar Tissue 3 3
Pneumonia 3 3
Nerve Damage 3 3
Cardiac Perforation 3 3
Chest Tightness/Pressure 2 2
Radiation Exposure, Unintended 2 2
Alteration In Body Temperature 2 2
Venipuncture 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Access Vascular, Inc. II Nov-08-2022
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
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 Bard Access Systems Inc. II Jul-01-2021
16 Bard Access Systems Inc. II Jun-30-2021
17 Bard Access Systems Inc. II May-20-2021
18 Bard Access Systems Inc. II Feb-06-2018
19 Bard Peripheral Vascular Inc II Feb-01-2023
20 Becton Dickinson & Company II May-21-2020
21 Medical Components, Inc dba MedComp II Oct-25-2019
22 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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