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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
L&Z US, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2323 2323
2019 2051 2051
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 1900 1900

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4476 4476
Break 1498 1498
Material Deformation 1422 1422
Adverse Event Without Identified Device or Use Problem 817 817
Fracture 809 809
Leak/Splash 674 674
Defective Component 592 592
Crack 577 577
Material Frayed 550 550
Component Incompatible 542 542
Failure to Infuse 373 373
Material Separation 340 340
Detachment of Device or Device Component 326 326
Material Puncture/Hole 309 309
Material Twisted/Bent 255 255
Device Dislodged or Dislocated 216 216
Contamination /Decontamination Problem 194 194
Obstruction of Flow 194 194
Physical Resistance/Sticking 188 188
Material Split, Cut or Torn 184 184
Material Rupture 158 158
Data Problem 135 135
Difficult to Remove 126 126
Deformation Due to Compressive Stress 125 125
Backflow 106 106
Burst Container or Vessel 96 96
Stretched 94 94
Material Fragmentation 91 91
Failure to Advance 80 80
Difficult or Delayed Separation 79 79
Appropriate Term/Code Not Available 78 78
Difficult to Flush 78 78
Hole In Material 77 77
Migration or Expulsion of Device 76 76
Malposition of Device 75 75
Device Markings/Labelling Problem 73 73
Difficult to Insert 71 71
Suction Problem 68 68
Improper or Incorrect Procedure or Method 65 65
Loss of or Failure to Bond 65 65
Migration 62 62
Difficult to Advance 60 60
Expiration Date Error 57 57
Positioning Problem 56 56
Complete Blockage 55 55
Unraveled Material 54 54
Device Operates Differently Than Expected 52 52
Defective Device 51 51
Component Missing 51 51
Kinked 49 49
Material Integrity Problem 49 49
Device Contamination with Chemical or Other Material 48 48
Material Protrusion/Extrusion 46 46
Entrapment of Device 46 46
Tear, Rip or Hole in Device Packaging 46 46
Detachment Of Device Component 44 44
Nonstandard Device 41 41
Misassembled 40 40
Unable to Obtain Readings 40 40
Flushing Problem 39 39
Infusion or Flow Problem 39 39
Insufficient Information 39 39
Fitting Problem 38 38
Disconnection 37 37
No Apparent Adverse Event 37 37
Mushroomed 33 33
Therapeutic or Diagnostic Output Failure 32 32
Patient-Device Incompatibility 29 29
Corroded 29 29
Loose or Intermittent Connection 29 29
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Device Damaged Prior to Use 26 26
Peeled/Delaminated 24 24
Physical Resistance 24 24
Connection Problem 23 23
No Flow 22 22
Coagulation in Device or Device Ingredient 22 22
Material Perforation 21 21
Occlusion Within Device 20 20
Restricted Flow rate 20 20
Improper Flow or Infusion 19 19
Split 19 19
Torn Material 19 19
Material Discolored 18 18
Unsealed Device Packaging 18 18
No Display/Image 17 17
Expulsion 17 17
Output Problem 17 17
Device Sensing Problem 15 15
Unintended Movement 15 15
Noise, Audible 15 15
Separation Problem 15 15
Contamination 14 14
Bent 14 14
Product Quality Problem 14 14
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Activation, Positioning or Separation Problem 13 13
Aspiration Issue 12 12
Gas/Air Leak 12 12
Air/Gas in Device 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6403 6403
No Consequences Or Impact To Patient 3124 3124
No Known Impact Or Consequence To Patient 2325 2325
Insufficient Information 565 565
Foreign Body In Patient 535 535
Swelling/ Edema 511 511
Erythema 456 456
No Code Available 251 251
Pain 245 245
No Patient Involvement 232 232
No Information 196 196
Unspecified Infection 160 160
Device Embedded In Tissue or Plaque 141 141
Thrombus 116 116
Extravasation 104 104
Swelling 98 98
Thrombosis/Thrombus 93 93
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Infiltration into Tissue 70 70
Hemorrhage/Bleeding 67 67
Thrombosis 50 50
Fever 47 47
Bacterial Infection 44 44
Failure of Implant 33 33
Discomfort 33 33
Injury 27 27
Blood Loss 27 27
Skin Inflammation/ Irritation 24 24
Hypersensitivity/Allergic reaction 24 24
Sepsis 23 23
Reaction 22 22
Dyspnea 22 22
Itching Sensation 21 21
Rash 21 21
Hematoma 20 20
Chest Pain 20 20
Death 20 20
Edema 18 18
Phlebitis 18 18
Needle Stick/Puncture 16 16
Chemical Exposure 16 16
Pleural Effusion 15 15
Arrhythmia 15 15
Inflammation 14 14
Bruise/Contusion 13 13
Cardiac Arrest 13 13
Cardiac Tamponade 12 12
Perforation of Vessels 12 12
Burning Sensation 11 11
Anxiety 11 11
Exposure to Body Fluids 11 11
Cellulitis 11 11
Purulent Discharge 11 11
Laceration(s) 11 11
Tissue Damage 10 10
Numbness 9 9
Nausea 9 9
Embolism 8 8
Embolus 8 8
Tachycardia 8 8
Fluid Discharge 8 8
Patient Problem/Medical Problem 7 7
Unspecified Tissue Injury 7 7
Urticaria 7 7
Discharge 7 7
Premature Labor 7 7
Air Embolism 7 7
Local Reaction 6 6
Tingling 6 6
Embolism/Embolus 6 6
Pericardial Effusion 5 5
Thromboembolism 5 5
Chills 5 5
Pneumothorax 5 5
Fungal Infection 5 5
Stroke/CVA 5 5
Irritation 5 5
Foreign Body Reaction 5 5
High Blood Pressure/ Hypertension 4 4
Pneumonia 4 4
Occlusion 4 4
Perforation 4 4
Respiratory Distress 4 4
Scar Tissue 4 4
Skin Erosion 4 4
Great Vessel Perforation 4 4
Convulsion/Seizure 4 4
Foreign Body Embolism 4 4
Abdominal Distention 3 3
Loss of consciousness 3 3
Lethargy 3 3
Ventricular Tachycardia 3 3
Septic Shock 3 3
Cardiac Perforation 3 3
Ulcer 3 3
Hernia 3 3
Anaphylactoid 3 3
Nerve Damage 3 3
Hypoglycemia 3 3
Low Blood Pressure/ Hypotension 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Sep-15-2023
2 Access Vascular, Inc II May-18-2023
3 Access Vascular, Inc. II Nov-08-2022
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
5 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
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 Arrow International Inc II Sep-19-2018
11 Arrow International Inc II Jul-08-2018
12 Arrow International Inc II May-30-2018
13 Arrow International Inc II Apr-10-2018
14 Arrow International Inc II Mar-14-2018
15 Arrow International Inc II Feb-22-2018
16 Arrow International Inc II Feb-13-2018
17 Bard Access Systems Inc. II Jul-01-2021
18 Bard Access Systems Inc. II Jun-30-2021
19 Bard Access Systems Inc. II May-20-2021
20 Bard Access Systems Inc. II Feb-06-2018
21 Bard Peripheral Vascular Inc II Feb-01-2023
22 Becton Dickinson & Company II May-21-2020
23 Medical Components, Inc dba MedComp II Oct-25-2019
24 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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