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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
  1.  K201452  Groshong NXT PICC Catheter
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 2802 2802
2024 790 790

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4645 4645
Material Deformation 1478 1478
Break 1296 1296
Fracture 810 810
Defective Component 803 803
Adverse Event Without Identified Device or Use Problem 787 787
Component Incompatible 570 570
Material Frayed 563 563
Crack 491 491
Leak/Splash 425 425
Failure to Infuse 392 392
Material Separation 339 339
Detachment of Device or Device Component 300 300
Material Puncture/Hole 282 282
Material Twisted/Bent 239 239
Contamination /Decontamination Problem 214 214
Device Dislodged or Dislocated 198 198
Obstruction of Flow 189 189
Material Split, Cut or Torn 177 177
Data Problem 174 174
Physical Resistance/Sticking 172 172
Deformation Due to Compressive Stress 144 144
Material Rupture 132 132
Difficult to Remove 112 112
Backflow 107 107
Stretched 102 102
Difficult or Delayed Separation 101 101
Difficult to Flush 78 78
Loss of or Failure to Bond 76 76
Material Fragmentation 72 72
Device Markings/Labelling Problem 67 67
Failure to Advance 64 64
Burst Container or Vessel 64 64
Improper or Incorrect Procedure or Method 62 62
Suction Problem 62 62
Migration 60 60
Difficult to Insert 59 59
Expiration Date Error 54 54
Difficult to Advance 53 53
Migration or Expulsion of Device 51 51
Misassembled 49 49
Tear, Rip or Hole in Device Packaging 48 48
Material Protrusion/Extrusion 47 47
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
Entrapment of Device 38 38
Defective Device 38 38
Corroded 37 37
Unraveled Material 36 36
Fitting Problem 33 33
Therapeutic or Diagnostic Output Failure 32 32
Infusion or Flow Problem 31 31
Material Integrity Problem 30 30
Positioning Problem 30 30
Appropriate Term/Code Not Available 30 30
Device Contamination with Chemical or Other Material 29 29
Flushing Problem 28 28
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Expulsion 25 25
Insufficient Information 25 25
Coagulation in Device or Device Ingredient 24 24
Disconnection 23 23
Peeled/Delaminated 22 22
Loose or Intermittent Connection 22 22
Restricted Flow rate 20 20
Separation Problem 20 20
Device Damaged Prior to Use 19 19
Material Discolored 18 18
Unsealed Device Packaging 17 17
Patient-Device Incompatibility 17 17
Output Problem 17 17
Improper Flow or Infusion 16 16
Material Perforation 15 15
Misconnection 15 15
Nonstandard Device 14 14
No Display/Image 14 14
Activation Problem 14 14
Air/Gas in Device 14 14
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Connection Problem 13 13
Contamination 12 12
Noise, Audible 12 12
Unintended Movement 11 11
Gas/Air Leak 11 11
Unexpected Shutdown 11 11
Material Erosion 11 11
Product Quality Problem 11 11
Separation Failure 11 11
Device Sensing Problem 10 10
Illegible Information 10 10
No Flow 10 10
Component Misassembled 9 9
Activation, Positioning or Separation Problem 9 9
Reflux within Device 9 9
Device Slipped 9 9
Difficult or Delayed Positioning 9 9
Degraded 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7779 7779
No Consequences Or Impact To Patient 2697 2697
No Known Impact Or Consequence To Patient 1047 1047
Insufficient Information 652 652
Swelling/ Edema 557 557
Foreign Body In Patient 545 545
Erythema 460 460
Pain 245 245
No Patient Involvement 163 163
Unspecified Infection 150 150
No Code Available 121 121
Extravasation 110 110
Device Embedded In Tissue or Plaque 107 107
Thrombosis/Thrombus 106 106
Thrombus 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 81 81
No Information 76 76
Infiltration into Tissue 71 71
Hemorrhage/Bleeding 68 68
Swelling 64 64
Fever 45 45
Discomfort 41 41
Failure of Implant 40 40
Bacterial Infection 37 37
Thrombosis 27 27
Skin Inflammation/ Irritation 27 27
Hypersensitivity/Allergic reaction 26 26
Purulent Discharge 23 23
Injury 23 23
Chemical Exposure 21 21
Dyspnea 21 21
Phlebitis 20 20
Rash 19 19
Hematoma 19 19
Sepsis 19 19
Blood Loss 17 17
Needle Stick/Puncture 17 17
Itching Sensation 17 17
Death 16 16
Reaction 16 16
Arrhythmia 15 15
Bruise/Contusion 14 14
Cardiac Arrest 14 14
Perforation of Vessels 13 13
Exposure to Body Fluids 12 12
Edema 12 12
Inflammation 12 12
Unspecified Tissue Injury 12 12
Pleural Effusion 11 11
Cellulitis 11 11
Chest Pain 11 11
Laceration(s) 10 10
Cardiac Tamponade 10 10
Anxiety 9 9
Nausea 9 9
Fluid Discharge 8 8
Embolism/Embolus 8 8
Air Embolism 7 7
Discharge 7 7
Premature Labor 7 7
Fungal Infection 6 6
Burning Sensation 6 6
Tachycardia 6 6
Stroke/CVA 6 6
Embolism 5 5
Foreign Body Reaction 5 5
Local 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
Great Vessel Perforation 4 4
Tingling 4 4
Chills 4 4
Irritation 4 4
High Blood Pressure/ Hypertension 4 4
Hypoglycemia 4 4
Low Blood Pressure/ Hypotension 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
Pallor 3 3
Obstruction/Occlusion 2 2
Loss of consciousness 2 2
Sedation 2 2
Confusion/ Disorientation 2 2
Lethargy 2 2
Thromboembolism 2 2
Skin Irritation 2 2
Distress 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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