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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 1
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&Z US, INC.
  SUBSTANTIALLY EQUIVALENT 3
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2051 2051
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 2803 2803
2024 1057 1057

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4762 4762
Material Deformation 1502 1502
Break 1317 1317
Fracture 815 815
Defective Component 810 810
Adverse Event Without Identified Device or Use Problem 794 794
Material Frayed 572 572
Component Incompatible 571 571
Crack 493 493
Leak/Splash 427 427
Failure to Infuse 398 398
Material Separation 348 348
Detachment of Device or Device Component 309 309
Material Puncture/Hole 284 284
Material Twisted/Bent 243 243
Contamination /Decontamination Problem 217 217
Device Dislodged or Dislocated 205 205
Obstruction of Flow 192 192
Material Split, Cut or Torn 178 178
Data Problem 176 176
Physical Resistance/Sticking 174 174
Deformation Due to Compressive Stress 145 145
Material Rupture 134 134
Difficult to Remove 120 120
Difficult or Delayed Separation 110 110
Backflow 107 107
Stretched 104 104
Loss of or Failure to Bond 79 79
Difficult to Flush 78 78
Material Fragmentation 75 75
Device Markings/Labelling Problem 68 68
Burst Container or Vessel 65 65
Improper or Incorrect Procedure or Method 65 65
Failure to Advance 65 65
Suction Problem 62 62
Migration 61 61
Difficult to Insert 60 60
Difficult to Advance 54 54
Expiration Date Error 54 54
Migration or Expulsion of Device 51 51
Misassembled 49 49
Material Protrusion/Extrusion 49 49
Tear, Rip or Hole in Device Packaging 48 48
Component Missing 44 44
Malposition of Device 43 43
Unable to Obtain Readings 41 41
Complete Blockage 41 41
No Apparent Adverse Event 41 41
Corroded 38 38
Entrapment of Device 38 38
Defective Device 38 38
Unraveled Material 36 36
Material Integrity Problem 33 33
Fitting Problem 33 33
Therapeutic or Diagnostic Output Failure 32 32
Infusion or Flow Problem 31 31
Appropriate Term/Code Not Available 30 30
Positioning Problem 30 30
Insufficient Information 29 29
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Device Contamination with Chemical or Other Material 29 29
Flushing Problem 28 28
Expulsion 27 27
Coagulation in Device or Device Ingredient 24 24
Disconnection 23 23
Loose or Intermittent Connection 22 22
Peeled/Delaminated 22 22
Restricted Flow rate 20 20
Separation Problem 20 20
Device Damaged Prior to Use 19 19
Material Discolored 18 18
Patient-Device Incompatibility 17 17
Output Problem 17 17
Unsealed Device Packaging 17 17
Improper Flow or Infusion 16 16
Misconnection 16 16
Activation Problem 16 16
Material Perforation 15 15
Nonstandard Device 14 14
Air/Gas in Device 14 14
No Display/Image 14 14
Connection Problem 13 13
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Noise, Audible 12 12
Contamination 12 12
Device Sensing Problem 11 11
Product Quality Problem 11 11
Gas/Air Leak 11 11
Material Erosion 11 11
Unexpected Shutdown 11 11
Separation Failure 11 11
Unintended Movement 11 11
Illegible Information 10 10
Activation, Positioning or Separation Problem 10 10
No Flow 10 10
Difficult or Delayed Positioning 9 9
Component Misassembled 9 9
Reflux within Device 9 9
Device Slipped 9 9
Partial Blockage 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7982 7982
No Consequences Or Impact To Patient 2697 2697
No Known Impact Or Consequence To Patient 1047 1047
Insufficient Information 668 668
Swelling/ Edema 566 566
Foreign Body In Patient 563 563
Erythema 460 460
Pain 254 254
No Patient Involvement 163 163
Unspecified Infection 151 151
No Code Available 121 121
Extravasation 112 112
Device Embedded In Tissue or Plaque 109 109
Thrombosis/Thrombus 107 107
Thrombus 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
No Information 76 76
Infiltration into Tissue 72 72
Hemorrhage/Bleeding 69 69
Swelling 64 64
Fever 45 45
Discomfort 43 43
Failure of Implant 42 42
Bacterial Infection 38 38
Thrombosis 27 27
Skin Inflammation/ Irritation 27 27
Hypersensitivity/Allergic reaction 26 26
Purulent Discharge 23 23
Injury 23 23
Chemical Exposure 22 22
Dyspnea 22 22
Phlebitis 20 20
Rash 20 20
Itching Sensation 19 19
Hematoma 19 19
Sepsis 19 19
Blood Loss 17 17
Needle Stick/Puncture 17 17
Reaction 16 16
Death 16 16
Bruise/Contusion 16 16
Arrhythmia 16 16
Cardiac Arrest 15 15
Inflammation 15 15
Perforation of Vessels 13 13
Exposure to Body Fluids 12 12
Edema 12 12
Unspecified Tissue Injury 12 12
Cellulitis 11 11
Chest Pain 11 11
Pleural Effusion 11 11
Laceration(s) 10 10
Cardiac Tamponade 10 10
Anxiety 9 9
Burning Sensation 9 9
Nausea 9 9
Fluid Discharge 9 9
Embolism/Embolus 8 8
Air Embolism 7 7
Discharge 7 7
Premature Labor 7 7
Fungal Infection 6 6
Tachycardia 6 6
Stroke/CVA 6 6
Local Reaction 6 6
Low Blood Pressure/ Hypotension 5 5
Embolism 5 5
Foreign Body Reaction 5 5
Tissue Damage 5 5
Numbness 5 5
Urticaria 5 5
Convulsion/Seizure 5 5
Foreign Body Embolism 4 4
Patient Problem/Medical Problem 4 4
Pneumothorax 4 4
Scar Tissue 4 4
Anaphylactoid 4 4
Great Vessel Perforation 4 4
Tingling 4 4
Chills 4 4
Irritation 4 4
High Blood Pressure/ Hypertension 4 4
Hypoglycemia 4 4
Nerve Damage 3 3
Occlusion 3 3
Emotional Changes 3 3
Pulmonary Embolism 3 3
Ulcer 3 3
Septic Shock 3 3
Perforation 3 3
Skin Erosion 3 3
Cardiac Perforation 3 3
Loss of consciousness 3 3
Pallor 3 3
Obstruction/Occlusion 2 2
Sedation 2 2
Confusion/ Disorientation 2 2
Lethargy 2 2
Thromboembolism 2 2
Skin Irritation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Oct-05-2023
2 ARROW INTERNATIONAL Inc. II Sep-15-2023
3 Access Vascular, Inc II Oct-13-2023
4 Access Vascular, Inc II May-18-2023
5 Access Vascular, Inc. II Nov-08-2022
6 Angiodynamics, Inc. II Jun-17-2020
7 Arrow International Inc II Feb-14-2020
8 Arrow International Inc II Jun-16-2019
9 Arrow International Inc II May-16-2019
10 Bard Access Systems Inc. II Jul-01-2021
11 Bard Access Systems Inc. II Jun-30-2021
12 Bard Access Systems Inc. II May-20-2021
13 Bard Peripheral Vascular Inc II Feb-01-2023
14 Becton Dickinson & Company II May-21-2020
15 Medical Components, Inc dba MedComp II Oct-25-2019
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