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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device port & catheter, implanted, subcutaneous, intravascular
Product CodeLJT
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 878 878
2019 765 765
2020 959 959
2021 1285 1285
2022 1334 1334
2023 768 768

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1783 1783
Fluid/Blood Leak 955 955
Adverse Event Without Identified Device or Use Problem 845 845
Material Separation 610 610
Deformation Due to Compressive Stress 521 521
Break 497 497
Suction Problem 455 455
Migration 408 408
Obstruction of Flow 306 306
Naturally Worn 303 303
Difficult to Flush 297 297
Detachment of Device or Device Component 205 205
Defective Component 186 186
Component Missing 178 178
Material Protrusion/Extrusion 145 145
Appropriate Term/Code Not Available 133 133
Difficult to Remove 121 121
Disconnection 116 116
Failure to Infuse 110 110
Migration or Expulsion of Device 107 107
Material Deformation 106 106
Stretched 103 103
Failure to Advance 82 82
Air/Gas in Device 82 82
Material Puncture/Hole 81 81
Leak/Splash 66 66
Dent in Material 59 59
Device Dislodged or Dislocated 57 57
Difficult to Insert 56 56
Improper or Incorrect Procedure or Method 55 55
Crack 54 54
Material Frayed 50 50
Tear, Rip or Hole in Device Packaging 50 50
Blocked Connection 47 47
Material Twisted/Bent 46 46
Expulsion 40 40
Device Contamination with Chemical or Other Material 37 37
Component Incompatible 37 37
Difficult or Delayed Separation 36 36
Material Split, Cut or Torn 36 36
Material Rupture 32 32
Peeled/Delaminated 30 30
Device Tipped Over 28 28
Material Integrity Problem 28 28
Physical Resistance/Sticking 28 28
Insufficient Information 28 28
Infusion or Flow Problem 26 26
Aspiration Issue 26 26
Loose or Intermittent Connection 25 25
Material Discolored 22 22
Entrapment of Device 22 22
Component Misassembled 22 22
Material Fragmentation 21 21
Partial Blockage 20 20
Device Appears to Trigger Rejection 20 20
Malposition of Device 20 20
Missing Information 19 19
Fitting Problem 17 17
Connection Problem 17 17
Restricted Flow rate 17 17
Contamination 17 17
Complete Blockage 16 16
Contamination /Decontamination Problem 16 16
Device Contaminated During Manufacture or Shipping 16 16
Use of Device Problem 15 15
Expiration Date Error 15 15
Detachment Of Device Component 15 15
Flushing Problem 15 15
Nonstandard Device 14 14
Unsealed Device Packaging 14 14
Device Markings/Labelling Problem 14 14
Packaging Problem 14 14
Inaccurate Information 12 12
Defective Device 12 12
Device Damaged Prior to Use 12 12
Reflux within Device 12 12
Separation Failure 11 11
Patient-Device Incompatibility 11 11
Backflow 10 10
Difficult to Advance 9 9
Loss of or Failure to Bond 8 8
Material Too Rigid or Stiff 8 8
Separation Problem 8 8
Scratched Material 8 8
No Apparent Adverse Event 7 7
Kinked 7 7
Degraded 7 7
Material Erosion 7 7
Unraveled Material 7 7
Device Slipped 6 6
Material Perforation 6 6
Incomplete or Missing Packaging 6 6
Device-Device Incompatibility 6 6
No Display/Image 6 6
Burst Container or Vessel 6 6
Radiation Leak 6 6
Mechanical Problem 6 6
Melted 6 6
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2105 2105
No Consequences Or Impact To Patient 1138 1138
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 382 382
Pain 336 336
Foreign Body In Patient 264 264
No Known Impact Or Consequence To Patient 231 231
Insufficient Information 231 231
No Patient Involvement 203 203
Injury 188 188
Arrhythmia 178 178
Extravasation 156 156
Swelling/ Edema 153 153
Unspecified Infection 150 150
Device Embedded In Tissue or Plaque 98 98
Swelling 77 77
Embolism 57 57
Skin Erosion 56 56
Thrombosis/Thrombus 56 56
Discomfort 50 50
Pneumothorax 42 42
Erythema 35 35
Thrombus 35 35
Embolism/Embolus 30 30
Sepsis 30 30
Chest Pain 28 28
Bacterial Infection 27 27
Phlebitis 23 23
Infiltration into Tissue 22 22
Fever 22 22
Neck Pain 22 22
No Information 21 21
Hematoma 20 20
Hemorrhage/Bleeding 20 20
Bruise/Contusion 20 20
Failure of Implant 19 19
No Code Available 19 19
Burning Sensation 18 18
Itching Sensation 18 18
Hypersensitivity/Allergic reaction 17 17
Inflammation 17 17
Thrombosis 17 17
Edema 16 16
Rash 15 15
Local Reaction 15 15
Death 14 14
Pulmonary Embolism 13 13
Perforation of Vessels 13 13
Patient Problem/Medical Problem 12 12
Wound Dehiscence 12 12
Air Embolism 10 10
Hemothorax 10 10
Rupture 10 10
Reaction 7 7
Cellulitis 7 7
Perforation 7 7
Necrosis 6 6
Skin Discoloration 6 6
Implant Pain 6 6
Obstruction/Occlusion 5 5
Blood Loss 5 5
Chemical Exposure 4 4
Unspecified Tissue Injury 4 4
Palpitations 4 4
Post Operative Wound Infection 4 4
Numbness 4 4
Fungal Infection 4 4
Scar Tissue 4 4
Dyspnea 4 4
Cardiac Arrest 3 3
Apheresis 3 3
Erosion 3 3
Occlusion 3 3
Pleural Effusion 3 3
Pneumonia 3 3
Anxiety 3 3
Needle Stick/Puncture 3 3
Chills 3 3
Dizziness 3 3
Skin Inflammation/ Irritation 3 3
Foreign Body Embolism 3 3
Pericardial Effusion 3 3
Tissue Breakdown 3 3
Decreased Respiratory Rate 3 3
Cardiac Perforation 2 2
Caustic/Chemical Burns 2 2
Respiratory Failure 2 2
Confusion/ Disorientation 2 2
Fluid Discharge 2 2
Vascular Dissection 2 2
Skin Infection 2 2
Post Traumatic Wound Infection 2 2
Urticaria 2 2
Internal Organ Perforation 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Irritation 2 2
Seizures 2 2
Tachycardia 2 2
Exposure to Body Fluids 2 2
Anaphylactic Shock 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Nov-21-2019
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Oct-05-2018
4 Angiodynamics, Inc. II Oct-25-2022
5 Bard Peripheral Vascular Inc II May-10-2021
6 Bard Peripheral Vascular Inc II May-12-2020
7 Bard Peripheral Vascular Inc II Mar-26-2020
8 Bard Peripheral Vascular Inc II Nov-27-2019
9 Bard Peripheral Vascular Inc II Jul-25-2019
10 Bard Peripheral Vascular Inc II May-09-2018
11 Cook Vascular Inc. II Mar-27-2018
12 Medical Components, Inc dba MedComp II Mar-08-2021
13 Medical Components, Inc dba MedComp II Mar-29-2018
14 Medical Components, Inc dba MedComp II Feb-06-2018
15 Smiths Medical ASD Inc. II Jul-04-2020
16 Smiths Medical ASD Inc. II Oct-24-2019
17 Smiths Medical ASD Inc. II Mar-15-2018
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