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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
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
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
VYGON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 2804 2804
2024 4246 4246
2025 1312 1389

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6657 6657
Material Deformation 1662 1739
Break 1355 1355
Defective Component 904 904
Fracture 842 842
Adverse Event Without Identified Device or Use Problem 799 799
Material Frayed 625 625
Component Incompatible 614 614
Crack 496 496
Failure to Infuse 415 415
Material Separation 411 411
Contamination /Decontamination Problem 340 340
Leak/Splash 293 293
Detachment of Device or Device Component 251 251
Material Twisted/Bent 225 225
Data Problem 223 223
Material Puncture/Hole 217 217
Device Dislodged or Dislocated 211 211
Obstruction of Flow 197 197
Difficult or Delayed Separation 163 163
Material Split, Cut or Torn 156 156
Physical Resistance/Sticking 137 137
Deformation Due to Compressive Stress 136 136
Difficult to Remove 135 135
Stretched 126 126
Loss of or Failure to Bond 123 123
Backflow 119 119
Material Rupture 96 96
Activation Problem 89 89
Difficult to Flush 85 85
Improper or Incorrect Procedure or Method 80 80
Device Markings/Labelling Problem 73 73
Material Fragmentation 72 72
Migration 65 65
Material Protrusion/Extrusion 64 64
Burst Container or Vessel 63 63
Suction Problem 63 63
Difficult to Insert 57 57
No Apparent Adverse Event 57 57
Difficult to Advance 51 51
Failure to Advance 49 49
Misassembled 49 49
Tear, Rip or Hole in Device Packaging 49 49
Migration or Expulsion of Device 48 48
Expiration Date Error 45 45
Expulsion 44 44
Component Missing 43 43
Unable to Obtain Readings 43 43
Material Integrity Problem 40 40
Corroded 37 37

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11456 11533
No Consequences Or Impact To Patient 1892 1892
Insufficient Information 852 900
Swelling/ Edema 757 757
Foreign Body In Patient 680 680
Erythema 471 471
Pain 451 451
Extravasation 262 262
No Known Impact Or Consequence To Patient 194 194
Thrombosis/Thrombus 188 188
Unspecified Infection 146 146
No Patient Involvement 120 120
Hemorrhage/Bleeding 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 92
Device Embedded In Tissue or Plaque 86 86
Infiltration into Tissue 72 72
Discomfort 69 69
Thrombus 65 65
No Code Available 57 57
Failure of Implant 51 51
Fever 48 48
Skin Inflammation/ Irritation 45 45
Bacterial Infection 39 39
Hypersensitivity/Allergic reaction 34 34
Swelling 34 34
Inflammation 33 33
Burning Sensation 32 32
Dyspnea 31 31
Needle Stick/Puncture 27 27
Chemical Exposure 25 25
Sepsis 23 23
No Information 23 23
Arrhythmia 22 22
Hematoma 22 22
Phlebitis 21 21
Purulent Discharge 21 21
Rash 20 20
Itching Sensation 20 20
Distress 19 19
Anxiety 18 18
Unspecified Tissue Injury 16 16
Perforation of Vessels 16 16
Bruise/Contusion 16 16
Pleural Effusion 15 15
Cardiac Arrest 14 14
Anaphylactoid 13 13
Nausea 12 12
Laceration(s) 12 12
Chest Pain 11 11
Injury 11 11

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 Access Systems, Inc. I Apr-16-2025
13 Bard Peripheral Vascular Inc II Feb-01-2023
14 Becton Dickinson & Company II May-21-2020
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