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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 364 364

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2023 2023
Adverse Event Without Identified Device or Use Problem 1006 1006
Fluid/Blood Leak 917 917
Material Separation 741 741
Deformation Due to Compressive Stress 622 622
Migration 495 495
Suction Problem 493 493
Difficult to Flush 364 364
Naturally Worn 363 363
Obstruction of Flow 337 337
Break 301 301
Detachment of Device or Device Component 196 196
Material Protrusion/Extrusion 151 151
Disconnection 130 130
Stretched 128 128
Component Missing 128 128
Difficult to Remove 126 126
Defective Component 118 118
Material Puncture/Hole 102 102
Material Deformation 93 93
Migration or Expulsion of Device 92 92
Failure to Advance 91 91
Air/Gas in Device 90 90
Failure to Infuse 87 87
Appropriate Term/Code Not Available 81 81
Difficult to Insert 65 65
Blocked Connection 63 63
Dent in Material 60 60
Expulsion 59 59
Leak/Splash 57 57
Improper or Incorrect Procedure or Method 56 56
Tear, Rip or Hole in Device Packaging 51 51
Material Integrity Problem 48 48
Material Split, Cut or Torn 46 46
Device Dislodged or Dislocated 44 44
Physical Resistance/Sticking 43 43
Material Twisted/Bent 43 43
Difficult or Delayed Separation 43 43
Crack 41 41
Loose or Intermittent Connection 32 32
Entrapment of Device 32 32
Device Tipped Over 31 31
Material Frayed 30 30
Device Appears to Trigger Rejection 29 29
Infusion or Flow Problem 27 27
Insufficient Information 27 27
Device Contamination with Chemical or Other Material 25 25
Device Damaged Prior to Use 25 25
Component Misassembled 24 24
Peeled/Delaminated 24 24
Component Incompatible 24 24
Missing Information 23 23
Material Discolored 22 22
Malposition of Device 22 22
Device Contaminated During Manufacture or Shipping 21 21
Partial Blockage 20 20
Fitting Problem 19 19
Packaging Problem 19 19
Device Markings/Labelling Problem 18 18
Material Fragmentation 18 18
Loss of or Failure to Bond 17 17
Contamination 17 17
Complete Blockage 16 16
Unraveled Material 16 16
Material Rupture 16 16
Poor Quality Image 15 15
Restricted Flow rate 15 15
Contamination /Decontamination Problem 15 15
Connection Problem 15 15
Separation Problem 15 15
Flushing Problem 14 14
Nonstandard Device 14 14
Reflux within Device 14 14
Unsealed Device Packaging 12 12
Separation Failure 12 12
Difficult to Advance 12 12
Inaccurate Information 12 12
Defective Device 10 10
Degraded 10 10
Backflow 9 9
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Scratched Material 8 8
Patient-Device Incompatibility 8 8
Material Erosion 8 8
Material Too Rigid or Stiff 8 8
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6
Expiration Date Error 6 6
Device-Device Incompatibility 6 6
Use of Device Problem 6 6
Melted 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
Material Opacification 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2602 2602
No Consequences Or Impact To Patient 708 708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 472 472
Pain 323 323
Insufficient Information 254 254
Unspecified Infection 214 214
Injury 183 183
Arrhythmia 182 182
Swelling/ Edema 172 172
Extravasation 170 170
Foreign Body In Patient 162 162
No Patient Involvement 150 150
Thrombosis/Thrombus 103 103
No Known Impact Or Consequence To Patient 89 89
Device Embedded In Tissue or Plaque 88 88
Swelling 59 59
Skin Erosion 57 57
Embolism 55 55
Bacterial Infection 46 46
Sepsis 44 44
Pneumothorax 43 43
Discomfort 43 43
Embolism/Embolus 40 40
Chest Pain 33 33
Failure of Implant 30 30
Erythema 26 26
Thrombus 25 25
Phlebitis 23 23
Hemorrhage/Bleeding 22 22
Hypersensitivity/Allergic reaction 22 22
Infiltration into Tissue 21 21
Hematoma 20 20
Neck Pain 20 20
Burning Sensation 19 19
Pulmonary Embolism 19 19
Bruise/Contusion 18 18
Itching Sensation 18 18
Inflammation 17 17
Fever 15 15
Perforation of Vessels 14 14
Wound Dehiscence 13 13
Rash 13 13
Edema 12 12
Death 11 11
Fungal Infection 10 10
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
Obstruction/Occlusion 7 7
Necrosis 6 6
Cellulitis 6 6
Numbness 6 6
Unspecified Tissue Injury 5 5
Reaction 5 5
Needle Stick/Puncture 5 5
Post Operative Wound Infection 4 4
Chemical Exposure 4 4
Foreign Body Embolism 4 4
Chills 4 4
Dizziness 4 4
Dyspnea 4 4
High Blood Pressure/ Hypertension 4 4
Pneumonia 4 4
Skin Discoloration 4 4
Skin Infection 4 4
Skin Inflammation/ Irritation 4 4
Cough 3 3
Scar Tissue 3 3
Pleural Effusion 3 3
Perforation 3 3
Headache 3 3
Erosion 3 3
Abdominal Pain 3 3
Anxiety 3 3
Pericardial Effusion 3 3
Tissue Breakdown 3 3
Fluid Discharge 3 3
Blood Loss 3 3
Cardiac Perforation 3 3
Decreased Respiratory Rate 3 3
Palpitations 3 3
Post Traumatic Wound Infection 2 2
Caustic/Chemical Burns 2 2
Confusion/ Disorientation 2 2
Patient Problem/Medical Problem 2 2
Convulsion/Seizure 2 2
Vascular Dissection 2 2
Distress 2 2
Cardiac Tamponade 2 2
Tachycardia 2 2
Apheresis 2 2
Anaphylactic Shock 2 2
Anemia 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Exposure to Body Fluids 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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