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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 808 808

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2185 2185
Adverse Event Without Identified Device or Use Problem 1146 1146
Fluid/Blood Leak 976 976
Material Separation 827 827
Deformation Due to Compressive Stress 686 686
Migration 556 556
Suction Problem 540 540
Difficult to Flush 402 402
Naturally Worn 398 398
Obstruction of Flow 360 360
Break 302 302
Detachment of Device or Device Component 204 204
Material Protrusion/Extrusion 154 154
Difficult to Remove 147 147
Stretched 143 143
Disconnection 139 139
Component Missing 131 131
Defective Component 120 120
Material Puncture/Hole 109 109
Material Deformation 95 95
Air/Gas in Device 94 94
Failure to Advance 93 93
Migration or Expulsion of Device 92 92
Failure to Infuse 87 87
Appropriate Term/Code Not Available 81 81
Difficult to Insert 75 75
Expulsion 71 71
Blocked Connection 70 70
Improper or Incorrect Procedure or Method 66 66
Material Integrity Problem 63 63
Dent in Material 60 60
Leak/Splash 57 57
Tear, Rip or Hole in Device Packaging 55 55
Material Split, Cut or Torn 53 53
Physical Resistance/Sticking 53 53
Difficult or Delayed Separation 50 50
Material Twisted/Bent 48 48
Device Dislodged or Dislocated 44 44
Crack 43 43
Entrapment of Device 37 37
Device Appears to Trigger Rejection 36 36
Device Damaged Prior to Use 35 35
Loose or Intermittent Connection 34 34
Device Tipped Over 33 33
Material Frayed 30 30
Component Misassembled 29 29
Insufficient Information 29 29
Device Contamination with Chemical or Other Material 27 27
Infusion or Flow Problem 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
Packaging Problem 21 21
Unraveled Material 20 20
Contamination 20 20
Partial Blockage 20 20
Restricted Flow rate 19 19
Material Fragmentation 18 18
Loss of or Failure to Bond 18 18
Reflux within Device 18 18
Device Markings/Labelling Problem 18 18
Connection Problem 17 17
Poor Quality Image 17 17
Complete Blockage 17 17
Material Rupture 16 16
Separation Problem 16 16
Contamination /Decontamination Problem 15 15
Nonstandard Device 14 14
Flushing Problem 14 14
Unsealed Device Packaging 13 13
Difficult to Advance 13 13
Separation Failure 12 12
Inaccurate Information 12 12
Defective Device 11 11
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
Premature Separation 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
Burst Container or Vessel 6 6
Illegible Information 6 6
Inadequate Instructions for Healthcare Professional 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2804 2804
No Consequences Or Impact To Patient 708 708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 548 548
Pain 362 362
Unspecified Infection 296 296
Insufficient Information 264 264
Swelling/ Edema 192 192
Extravasation 190 190
Arrhythmia 183 183
Injury 183 183
Foreign Body In Patient 173 173
No Patient Involvement 150 150
Thrombosis/Thrombus 148 148
Bacterial Infection 111 111
No Known Impact Or Consequence To Patient 89 89
Device Embedded In Tissue or Plaque 88 88
Sepsis 71 71
Skin Erosion 61 61
Swelling 59 59
Embolism 55 55
Embolism/Embolus 45 45
Discomfort 44 44
Pneumothorax 43 43
Chest Pain 40 40
Failure of Implant 32 32
Erythema 30 30
Pulmonary Embolism 29 29
Hemorrhage/Bleeding 25 25
Thrombus 25 25
Neck Pain 24 24
Infiltration into Tissue 24 24
Phlebitis 23 23
Inflammation 22 22
Hypersensitivity/Allergic reaction 22 22
Hematoma 22 22
Fever 20 20
Burning Sensation 19 19
Bruise/Contusion 18 18
Itching Sensation 18 18
Rash 16 16
Cellulitis 15 15
Fungal Infection 15 15
Perforation of Vessels 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
Septic Shock 8 8
Obstruction/Occlusion 8 8
Skin Discoloration 7 7
Tachycardia 7 7
Numbness 6 6
Necrosis 6 6
Skin Infection 6 6
Skin Inflammation/ Irritation 5 5
Unspecified Tissue Injury 5 5
Scar Tissue 5 5
Dyspnea 5 5
Endocarditis 5 5
Reaction 5 5
Dizziness 5 5
Needle Stick/Puncture 5 5
Post Operative Wound Infection 4 4
Chemical Exposure 4 4
Chills 4 4
Stroke/CVA 4 4
Cardiac Arrest 4 4
Pneumonia 4 4
High Blood Pressure/ Hypertension 4 4
Headache 4 4
Foreign Body Embolism 4 4
Unspecified Mental, Emotional or Behavioural Problem 3 3
Pericardial Effusion 3 3
Convulsion/Seizure 3 3
Cough 3 3
Pleural Effusion 3 3
Perforation 3 3
Erosion 3 3
Abdominal Pain 3 3
Purulent Discharge 3 3
Anxiety 3 3
Blood Loss 3 3
Cardiac Perforation 3 3
Tissue Breakdown 3 3
Fluid Discharge 3 3
Decreased Respiratory Rate 3 3
Palpitations 3 3
Post Traumatic Wound Infection 2 2
Patient Problem/Medical Problem 2 2
Caustic/Chemical Burns 2 2
Confusion/ Disorientation 2 2
Distress 2 2
Deformity/ Disfigurement 2 2
Great Vessel Perforation 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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