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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
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
NAVI MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 2804 2804
2024 4246 4246

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 5975 5975
Material Deformation 1536 1536
Break 1272 1272
Defective Component 860 860
Fracture 803 803
Adverse Event Without Identified Device or Use Problem 780 780
Material Frayed 603 603
Component Incompatible 598 598
Crack 477 477
Failure to Infuse 400 400
Material Separation 395 395
Contamination /Decontamination Problem 281 281
Leak/Splash 261 261
Detachment of Device or Device Component 244 244
Material Twisted/Bent 212 212
Data Problem 209 209
Material Puncture/Hole 207 207
Device Dislodged or Dislocated 199 199
Obstruction of Flow 186 186
Difficult or Delayed Separation 147 147
Material Split, Cut or Torn 143 143
Physical Resistance/Sticking 136 136
Deformation Due to Compressive Stress 131 131
Difficult to Remove 128 128
Stretched 121 121
Loss of or Failure to Bond 118 118
Backflow 108 108
Material Rupture 94 94
Difficult to Flush 85 85
Improper or Incorrect Procedure or Method 75 75
Device Markings/Labelling Problem 69 69
Material Fragmentation 67 67
Burst Container or Vessel 63 63
Suction Problem 60 60
Material Protrusion/Extrusion 59 59
Migration 58 58
Difficult to Insert 57 57
No Apparent Adverse Event 53 53
Difficult to Advance 50 50
Failure to Advance 48 48
Activation Problem 48 48
Misassembled 46 46
Tear, Rip or Hole in Device Packaging 46 46
Migration or Expulsion of Device 46 46
Expiration Date Error 45 45
Unable to Obtain Readings 42 42
Component Missing 39 39
Corroded 37 37
Expulsion 36 36
Malposition of Device 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10422 10422
No Consequences Or Impact To Patient 1892 1892
Insufficient Information 792 792
Swelling/ Edema 702 702
Foreign Body In Patient 623 623
Erythema 464 464
Pain 387 387
Extravasation 229 229
No Known Impact Or Consequence To Patient 194 194
Thrombosis/Thrombus 169 169
Unspecified Infection 139 139
No Patient Involvement 120 120
Hemorrhage/Bleeding 90 90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 89 89
Device Embedded In Tissue or Plaque 81 81
Infiltration into Tissue 67 67
Thrombus 65 65
Discomfort 59 59
No Code Available 57 57
Failure of Implant 46 46
Fever 46 46
Skin Inflammation/ Irritation 39 39
Bacterial Infection 38 38
Swelling 34 34
Hypersensitivity/Allergic reaction 31 31
Inflammation 30 30
Dyspnea 27 27
Needle Stick/Puncture 26 26
Chemical Exposure 24 24
No Information 23 23
Sepsis 22 22
Phlebitis 21 21
Burning Sensation 21 21
Purulent Discharge 21 21
Hematoma 21 21
Arrhythmia 20 20
Rash 20 20
Itching Sensation 19 19
Anxiety 17 17
Unspecified Tissue Injury 16 16
Bruise/Contusion 15 15
Perforation of Vessels 14 14
Pleural Effusion 14 14
Cardiac Arrest 13 13
Anaphylactoid 12 12
Laceration(s) 12 12
Nausea 12 12
Chest Pain 11 11
Injury 11 11
Exposure to Body Fluids 10 10

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 Argon Medical Devices, Inc II Aug-16-2024
8 Arrow International Inc II Feb-14-2020
9 Bard Access Systems Inc. II Jul-01-2021
10 Bard Access Systems Inc. II Jun-30-2021
11 Bard Access Systems Inc. II May-20-2021
12 Bard Peripheral Vascular Inc II Feb-01-2023
13 Becton Dickinson & Company II May-21-2020
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