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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
2017 262 262
2018 878 878
2019 765 765
2020 959 959
2021 1288 1288
2022 662 662

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1421 1421
Fluid Leak 798 798
Break 495 495
Material Separation 430 430
Deformation Due to Compressive Stress 399 399
Suction Problem 348 348
Migration 301 301
Adverse Event Without Identified Device or Use Problem 292 292
Obstruction of Flow 255 255
Naturally Worn 250 250
Difficult to Flush 217 217
Detachment of Device or Device Component 182 182
Defective Component 180 180
Component Missing 176 176
Appropriate Term/Code Not Available 135 135
Difficult to Remove 126 126
Migration or Expulsion of Device 117 117
Material Protrusion/Extrusion 115 115
Failure to Infuse 108 108
Material Deformation 104 104
Disconnection 99 99
Leak/Splash 83 83
Stretched 74 74
Crack 72 72
Failure to Advance 62 62
Material Puncture/Hole 58 58
Air/Gas in Device 55 55
Device Dislodged or Dislocated 54 54
Material Frayed 50 50
Tear, Rip or Hole in Device Packaging 43 43
Improper or Incorrect Procedure or Method 41 41
Detachment Of Device Component 40 40
Dent in Material 39 39
Component Incompatible 37 37
Aspiration Issue 36 36
Material Twisted/Bent 36 36
Device Contamination with Chemical or Other Material 36 36
Difficult to Insert 35 35
Material Rupture 34 34
Peeled/Delaminated 30 30
Expulsion 29 29
Difficult or Delayed Separation 29 29
Blocked Connection 27 27
Material Split, Cut or Torn 26 26
Insufficient Information 26 26
Material Fragmentation 22 22
Infusion or Flow Problem 21 21
Partial Blockage 20 20
Loose or Intermittent Connection 20 20
Component Misassembled 20 20
Missing Information 17 17
Material Discolored 16 16
Entrapment of Device 16 16
Malposition of Device 16 16
Device Markings/Labelling Problem 15 15
Expiration Date Error 15 15
Contamination 15 15
Complete Blockage 14 14
Restricted Flow rate 14 14
Use of Device Problem 14 14
Material Integrity Problem 14 14
Packaging Problem 14 14
Contamination /Decontamination Problem 13 13
Connection Problem 13 13
Device Tipped Over 13 13
Unsealed Device Packaging 13 13
Flushing Problem 13 13
Kinked 12 12
Nonstandard Device 12 12
Device Issue 12 12
Inaccurate Information 12 12
Physical Resistance/Sticking 11 11
Device Damaged Prior to Use 11 11
Patient-Device Incompatibility 11 11
Backflow 11 11
Reflux within Device 10 10
Device Operates Differently Than Expected 10 10
Device Contaminated During Manufacture or Shipping 10 10
Fitting Problem 10 10
Defective Device 10 10
Difficult to Advance 9 9
Material Perforation 8 8
Device Appears to Trigger Rejection 8 8
Material Too Rigid or Stiff 8 8
Burst Container or Vessel 8 8
Scratched Material 8 8
Degraded 7 7
Material Erosion 7 7
Separation Failure 7 7
Incomplete or Missing Packaging 6 6
Device-Device Incompatibility 6 6
Misassembled 6 6
Mechanical Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6
Positioning Problem 5 5
Misassembly by Users 5 5
Melted 5 5
Inadequacy of Device Shape and/or Size 5 5
No Display/Image 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1377 1377
No Consequences Or Impact To Patient 1165 1165
No Known Impact Or Consequence To Patient 331 331
Pain 320 320
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
Foreign Body In Patient 242 242
No Patient Involvement 205 205
Injury 189 189
Extravasation 146 146
Swelling/ Edema 122 122
Device Embedded In Tissue or Plaque 119 119
Swelling 94 94
Unspecified Infection 82 82
Insufficient Information 75 75
Embolism 57 57
Discomfort 49 49
Skin Erosion 47 47
Thrombosis/Thrombus 36 36
No Code Available 35 35
Thrombus 35 35
Infiltration into Tissue 32 32
Erythema 31 31
No Information 31 31
Embolism/Embolus 24 24
Chest Pain 22 22
Death 21 21
Fever 20 20
Sepsis 20 20
Patient Problem/Medical Problem 20 20
Neck Pain 20 20
Edema 19 19
Bruise/Contusion 19 19
Thrombosis 17 17
Burning Sensation 17 17
Hypersensitivity/Allergic reaction 16 16
Itching Sensation 16 16
Bacterial Infection 15 15
Local Reaction 14 14
Hematoma 12 12
Hemorrhage/Bleeding 12 12
Inflammation 12 12
Pulmonary Embolism 12 12
Failure of Implant 11 11
Rash 11 11
Rupture 10 10
Perforation of Vessels 8 8
Air Embolism 8 8
Reaction 7 7
Blood Loss 7 7
Numbness 6 6
Cellulitis 6 6
Hemothorax 6 6
Necrosis 6 6
Perforation 6 6
Pneumothorax 5 5
Skin Discoloration 5 5
Dyspnea 5 5
Arrhythmia 5 5
Obstruction/Occlusion 5 5
Post Operative Wound Infection 5 5
Palpitations 5 5
Wound Dehiscence 4 4
Apheresis 3 3
Erosion 3 3
Cardiac Arrest 3 3
Scar Tissue 3 3
Occlusion 3 3
Chills 3 3
Dizziness 3 3
Tissue Breakdown 3 3
Decreased Respiratory Rate 3 3
Pericardial Effusion 3 3
Unspecified Tissue Injury 3 3
Implant Pain 3 3
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Foreign Body Embolism 2 2
Cardiac Perforation 2 2
Caustic/Chemical Burns 2 2
Respiratory Failure 2 2
Chemical Exposure 2 2
Fluid Discharge 2 2
Vascular Dissection 2 2
Weakness 2 2
Great Vessel Perforation 2 2
Post Traumatic Wound Infection 2 2
Skin Inflammation 2 2
Fungal Infection 2 2
Urticaria 2 2
Pleural Effusion 2 2
Pneumonia 2 2
High Blood Pressure/ Hypertension 2 2
Irritation 2 2
Seizures 2 2
Tachycardia 2 2
Vessel Or Plaque, Device Embedded In 2 2
Anaphylactic Shock 2 2
Foreign Body Reaction 2 2
Headache 2 2
Fall 1 1

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 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 Bard Peripheral Vascular Inc II May-09-2018
10 Cook Vascular Inc. II Mar-27-2018
11 Medical Components, Inc dba MedComp II Mar-08-2021
12 Medical Components, Inc dba MedComp II Mar-29-2018
13 Medical Components, Inc dba MedComp II Feb-06-2018
14 Medical Components, Inc dba MedComp II Mar-08-2017
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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