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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
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 765 765
2020 959 959
2021 1285 1285
2022 1334 1334
2023 1225 1225
2024 538 538

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2068 2068
Adverse Event Without Identified Device or Use Problem 1059 1059
Fluid/Blood Leak 945 945
Material Separation 771 771
Deformation Due to Compressive Stress 645 645
Migration 522 522
Suction Problem 517 517
Difficult to Flush 391 391
Naturally Worn 373 373
Obstruction of Flow 347 347
Break 301 301
Detachment of Device or Device Component 202 202
Material Protrusion/Extrusion 154 154
Disconnection 138 138
Stretched 134 134
Difficult to Remove 133 133
Component Missing 128 128
Defective Component 120 120
Material Puncture/Hole 105 105
Material Deformation 94 94
Failure to Advance 93 93
Migration or Expulsion of Device 92 92
Air/Gas in Device 91 91
Failure to Infuse 87 87
Appropriate Term/Code Not Available 81 81
Difficult to Insert 70 70
Blocked Connection 68 68
Expulsion 63 63
Dent in Material 60 60
Improper or Incorrect Procedure or Method 59 59
Leak/Splash 57 57
Material Integrity Problem 56 56
Tear, Rip or Hole in Device Packaging 51 51
Material Split, Cut or Torn 49 49
Physical Resistance/Sticking 47 47
Material Twisted/Bent 46 46
Device Dislodged or Dislocated 44 44
Difficult or Delayed Separation 43 43
Crack 41 41
Entrapment of Device 34 34
Loose or Intermittent Connection 33 33
Device Tipped Over 33 33
Device Appears to Trigger Rejection 32 32
Material Frayed 30 30
Device Damaged Prior to Use 30 30
Device Contamination with Chemical or Other Material 27 27
Infusion or Flow Problem 27 27
Component Misassembled 27 27
Insufficient Information 27 27
Component Incompatible 24 24
Peeled/Delaminated 24 24
Malposition of Device 23 23
Missing Information 23 23
Device Contaminated During Manufacture or Shipping 22 22
Material Discolored 22 22
Fitting Problem 21 21
Partial Blockage 20 20
Packaging Problem 20 20
Restricted Flow rate 19 19
Material Fragmentation 18 18
Loss of or Failure to Bond 18 18
Contamination 18 18
Device Markings/Labelling Problem 18 18
Unraveled Material 17 17
Material Rupture 16 16
Poor Quality Image 16 16
Complete Blockage 16 16
Connection Problem 16 16
Contamination /Decontamination Problem 15 15
Separation Problem 15 15
Flushing Problem 14 14
Nonstandard Device 14 14
Reflux within Device 14 14
Unsealed Device Packaging 13 13
Separation Failure 12 12
Difficult to Advance 12 12
Inaccurate Information 12 12
Defective Device 10 10
Patient-Device Incompatibility 10 10
Degraded 10 10
Backflow 9 9
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Scratched Material 8 8
Material Erosion 8 8
Material Too Rigid or Stiff 8 8
Melted 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 7 7
Dull, Blunt 7 7
Expiration Date Error 6 6
Device-Device Incompatibility 6 6
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6
Use of Device Problem 6 6
No Display/Image 6 6
Radiation Leak 6 6
Premature Separation 6 6
Illegible Information 6 6
Inadequate Instructions for Healthcare Professional 5 5
Burst Container or Vessel 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2684 2684
No Consequences Or Impact To Patient 708 708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 507 507
Pain 336 336
Insufficient Information 256 256
Unspecified Infection 242 242
Injury 183 183
Arrhythmia 182 182
Swelling/ Edema 179 179
Extravasation 178 178
Foreign Body In Patient 165 165
No Patient Involvement 150 150
Thrombosis/Thrombus 115 115
No Known Impact Or Consequence To Patient 89 89
Device Embedded In Tissue or Plaque 88 88
Bacterial Infection 71 71
Skin Erosion 59 59
Swelling 59 59
Embolism 55 55
Sepsis 49 49
Pneumothorax 43 43
Discomfort 43 43
Embolism/Embolus 40 40
Chest Pain 38 38
Failure of Implant 30 30
Erythema 29 29
Thrombus 25 25
Hemorrhage/Bleeding 24 24
Phlebitis 23 23
Hypersensitivity/Allergic reaction 22 22
Pulmonary Embolism 22 22
Neck Pain 22 22
Infiltration into Tissue 21 21
Inflammation 21 21
Hematoma 21 21
Burning Sensation 19 19
Itching Sensation 18 18
Bruise/Contusion 18 18
Fever 18 18
Rash 15 15
Perforation of Vessels 14 14
Fungal Infection 14 14
Wound Dehiscence 13 13
Edema 12 12
Death 11 11
No Information 10 10
Implant Pain 10 10
No Code Available 9 9
Thrombosis 9 9
Air Embolism 9 9
Local Reaction 9 9
Hemothorax 8 8
Cellulitis 8 8
Obstruction/Occlusion 7 7
Necrosis 6 6
Numbness 6 6
Skin Inflammation/ Irritation 5 5
Unspecified Tissue Injury 5 5
Dyspnea 5 5
Needle Stick/Puncture 5 5
Skin Discoloration 5 5
Reaction 5 5
Dizziness 5 5
Chills 4 4
Pneumonia 4 4
Post Operative Wound Infection 4 4
Chemical Exposure 4 4
Headache 4 4
Stroke/CVA 4 4
High Blood Pressure/ Hypertension 4 4
Scar Tissue 4 4
Skin Infection 4 4
Foreign Body Embolism 4 4
Cough 3 3
Septic Shock 3 3
Pleural Effusion 3 3
Perforation 3 3
Erosion 3 3
Cardiac Arrest 3 3
Abdominal Pain 3 3
Purulent Discharge 3 3
Blood Loss 3 3
Tissue Breakdown 3 3
Fluid Discharge 3 3
Pericardial Effusion 3 3
Decreased Respiratory Rate 3 3
Cardiac Perforation 3 3
Palpitations 3 3
Anxiety 3 3
Distress 2 2
Deformity/ Disfigurement 2 2
Cardiac Tamponade 2 2
Tachycardia 2 2
Caustic/Chemical Burns 2 2
Confusion/ Disorientation 2 2
Post Traumatic Wound Infection 2 2
Convulsion/Seizure 2 2
Vascular Dissection 2 2
Patient Problem/Medical Problem 2 2
Fatigue 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. II Oct-25-2022
4 Bard Peripheral Vascular Inc II May-10-2021
5 Bard Peripheral Vascular Inc II May-12-2020
6 Bard Peripheral Vascular Inc II Mar-26-2020
7 Bard Peripheral Vascular Inc II Nov-27-2019
8 Bard Peripheral Vascular Inc II Jul-25-2019
9 Medical Components, Inc dba MedComp II Mar-08-2021
10 Smiths Medical ASD Inc. II Jul-04-2020
11 Smiths Medical ASD Inc. II Oct-24-2019
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