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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 1288 1288
2022 1335 1335

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1488 1488
Fluid/Blood Leak 833 833
Adverse Event Without Identified Device or Use Problem 681 681
Break 486 486
Material Separation 464 464
Deformation Due to Compressive Stress 443 443
Suction Problem 373 373
Migration 333 333
Naturally Worn 276 276
Obstruction of Flow 271 271
Difficult to Flush 231 231
Detachment of Device or Device Component 189 189
Defective Component 180 180
Component Missing 175 175
Appropriate Term/Code Not Available 133 133
Material Protrusion/Extrusion 126 126
Failure to Infuse 109 109
Migration or Expulsion of Device 106 106
Material Deformation 104 104
Disconnection 103 103
Difficult to Remove 100 100
Stretched 85 85
Failure to Advance 69 69
Air/Gas in Device 63 63
Material Puncture/Hole 61 61
Leak/Splash 61 61
Device Dislodged or Dislocated 51 51
Material Frayed 50 50
Crack 46 46
Tear, Rip or Hole in Device Packaging 45 45
Improper or Incorrect Procedure or Method 45 45
Dent in Material 42 42
Material Twisted/Bent 42 42
Difficult to Insert 42 42
Component Incompatible 37 37
Device Contamination with Chemical or Other Material 35 35
Difficult or Delayed Separation 35 35
Blocked Connection 32 32
Material Rupture 31 31
Peeled/Delaminated 30 30
Expulsion 30 30
Material Split, Cut or Torn 27 27
Aspiration Issue 26 26
Insufficient Information 25 25
Loose or Intermittent Connection 21 21
Partial Blockage 20 20
Infusion or Flow Problem 20 20
Component Misassembled 20 20
Device Tipped Over 19 19
Material Fragmentation 18 18
Missing Information 18 18
Contamination 17 17
Material Discolored 16 16
Entrapment of Device 16 16
Detachment Of Device Component 15 15
Restricted Flow rate 15 15
Malposition of Device 15 15
Expiration Date Error 15 15
Physical Resistance/Sticking 15 15
Fitting Problem 14 14
Device Contaminated During Manufacture or Shipping 14 14
Device Markings/Labelling Problem 14 14
Contamination /Decontamination Problem 14 14
Connection Problem 14 14
Packaging Problem 14 14
Unsealed Device Packaging 14 14
Complete Blockage 14 14
Nonstandard Device 13 13
Device Damaged Prior to Use 13 13
Use of Device Problem 13 13
Flushing Problem 12 12
Inaccurate Information 12 12
Patient-Device Incompatibility 11 11
Material Integrity Problem 11 11
Reflux within Device 10 10
Device Appears to Trigger Rejection 10 10
Backflow 9 9
Difficult to Advance 9 9
Separation Failure 9 9
Defective Device 9 9
Scratched Material 8 8
Material Too Rigid or Stiff 8 8
Kinked 7 7
Degraded 7 7
Material Erosion 7 7
Burst Container or Vessel 6 6
Mechanical Problem 6 6
Melted 6 6
Device Slipped 6 6
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6
Device-Device Incompatibility 6 6
Incomplete or Missing Packaging 6 6
Material Perforation 6 6
No Apparent Adverse Event 6 6
Separation Problem 5 5
Illegible Information 5 5
Difficult to Open or Close 5 5
Misassembled 5 5
No Display/Image 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1628 1628
No Consequences Or Impact To Patient 1138 1138
Pain 307 307
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 305 305
No Known Impact Or Consequence To Patient 231 231
Foreign Body In Patient 228 228
No Patient Involvement 203 203
Insufficient Information 191 191
Injury 188 188
Arrhythmia 152 152
Extravasation 141 141
Swelling/ Edema 129 129
Unspecified Infection 111 111
Device Embedded In Tissue or Plaque 92 92
Swelling 77 77
Embolism 57 57
Discomfort 49 49
Skin Erosion 48 48
Thrombosis/Thrombus 44 44
Pneumothorax 38 38
Thrombus 35 35
Erythema 31 31
Sepsis 27 27
Embolism/Embolus 27 27
Phlebitis 22 22
Infiltration into Tissue 21 21
Chest Pain 21 21
No Information 21 21
Neck Pain 20 20
Fever 20 20
No Code Available 19 19
Bruise/Contusion 18 18
Bacterial Infection 17 17
Thrombosis 17 17
Burning Sensation 17 17
Hemorrhage/Bleeding 16 16
Edema 16 16
Inflammation 16 16
Hypersensitivity/Allergic reaction 16 16
Itching Sensation 16 16
Hematoma 14 14
Local Reaction 14 14
Death 14 14
Pulmonary Embolism 13 13
Rash 12 12
Failure of Implant 12 12
Patient Problem/Medical Problem 12 12
Wound Dehiscence 11 11
Rupture 10 10
Air Embolism 9 9
Hemothorax 9 9
Perforation of Vessels 8 8
Reaction 7 7
Cellulitis 6 6
Necrosis 6 6
Perforation 6 6
Skin Discoloration 5 5
Obstruction/Occlusion 5 5
Blood Loss 5 5
Numbness 4 4
Post Operative Wound Infection 4 4
Palpitations 4 4
Dyspnea 4 4
Cardiac Arrest 3 3
Apheresis 3 3
Erosion 3 3
Scar Tissue 3 3
Pleural Effusion 3 3
Occlusion 3 3
Decreased Respiratory Rate 3 3
Chills 3 3
Dizziness 3 3
Unspecified Tissue Injury 3 3
Implant Pain 3 3
Pericardial Effusion 3 3
Tissue Breakdown 3 3
Fluid Discharge 2 2
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Respiratory Failure 2 2
Caustic/Chemical Burns 2 2
Vascular Dissection 2 2
Foreign Body Embolism 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Urticaria 2 2
Anxiety 2 2
Cardiac Perforation 2 2
Post Traumatic Wound Infection 2 2
Needle Stick/Puncture 2 2
Fungal Infection 2 2
Pneumonia 2 2
High Blood Pressure/ Hypertension 2 2
Irritation 2 2
Seizures 2 2
Exposure to Body Fluids 2 2
Anaphylactic Shock 2 2
Anemia 2 2
Foreign Body Reaction 2 2
Headache 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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