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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, hemodialysis, implanted
Product CodeMSD
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
AMECO MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
ARROW INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
ASH ACCESS TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1
C B BARD, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1
C R BARD, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1
C.R. BARD
  SUBSTANTIALLY EQUIVALENT - KIT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT 1
DERMAPORT, INC
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
MARVAO MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 5
MEDCOMP
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCOMP (DBA MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDICAL COMPONENTS INC
  SUBSTANTIALLY EQUIVALENT - KIT 3
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS INC. (MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
PHASE ONE MEDICAL
  SUBSTANTIALLY EQUIVALENT - KIT 1
PRISTINE ACCESS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
R4 VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
REX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2014 506 506
2015 549 549
2016 532 532
2017 483 483
2018 462 462
2019 645 645
2020 401 401
2021 523 523
2022 610 610
2023 542 542
2024 140 140

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 755 755
Break 640 640
Crack 470 470
Leak/Splash 427 427
Fracture 420 420
Defective Component 340 340
Material Puncture/Hole 271 271
Material Deformation 229 229
Detachment of Device or Device Component 163 163
Deformation Due to Compressive Stress 147 147
Hole In Material 130 130
Material Separation 116 116
Adverse Event Without Identified Device or Use Problem 109 109
Material Integrity Problem 103 103
Device Dislodged or Dislocated 102 102
Device Operates Differently Than Expected 102 102
Stretched 98 98
Obstruction of Flow 95 95
Difficult to Remove 93 93
Material Opacification 91 91
Migration or Expulsion of Device 89 89
Kinked 82 82
Detachment Of Device Component 81 81
Restricted Flow rate 80 80
Insufficient Flow or Under Infusion 75 75
Insufficient Information 72 72
Air Leak 65 65
Material Protrusion/Extrusion 63 63
Appropriate Term/Code Not Available 61 61
Air/Gas in Device 61 61
Disconnection 59 59
Material Discolored 57 57
Material Frayed 51 51
Component Missing 51 51
Occlusion Within Device 49 49
Expulsion 48 48
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Infusion or Flow Problem 47 47
Failure to Advance 46 46
Product Quality Problem 43 43
Suction Problem 39 39
Migration 37 37
Connection Problem 35 35
Material Fragmentation 35 35
Difficult to Insert 33 33
Collapse 30 30
Material Twisted/Bent 30 30
Unraveled Material 30 30
Sticking 28 28
Failure To Adhere Or Bond 28 28
Physical Resistance/Sticking 27 27
Packaging Problem 26 26
Tear, Rip or Hole in Device Packaging 25 25
Split 23 23
Gas/Air Leak 23 23
Improper or Incorrect Procedure or Method 21 21
Loss of or Failure to Bond 21 21
Material Split, Cut or Torn 21 21
Unsealed Device Packaging 20 20
Material Rupture 19 19
Bent 19 19
Malposition of Device 19 19
Improper Flow or Infusion 18 18
Difficult or Delayed Separation 17 17
Torn Material 17 17
Component Falling 17 17
Loose or Intermittent Connection 17 17
Contamination /Decontamination Problem 16 16
Device Markings/Labelling Problem 15 15
Partial Blockage 15 15
Contamination 14 14
Device Contamination with Chemical or Other Material 14 14
Device Damaged Prior to Use 14 14
No Flow 14 14
Human-Device Interface Problem 13 13
Difficult to Flush 13 13
Defective Device 12 12
Separation Failure 12 12
Component Incompatible 11 11
Melted 10 10
Device Slipped 10 10
Reflux within Device 10 10
Failure to Infuse 10 10
Use of Device Problem 10 10
Mechanical Jam 10 10
Positioning Problem 10 10
Fitting Problem 9 9
Peeled/Delaminated 9 9
Inaccurate Flow Rate 9 9
Complete Blockage 8 8
Nonstandard Device 8 8
Device Inoperable 8 8
Cut In Material 8 8
Difficult to Advance 8 8
Aspiration Issue 8 8
Scratched Material 8 8
No Fail-Safe Mechanism 7 7
Unintended Movement 7 7
Component Misassembled 7 7
Separation Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1584 1584
No Consequences Or Impact To Patient 1295 1295
No Known Impact Or Consequence To Patient 1273 1273
No Patient Involvement 229 229
Hemorrhage/Bleeding 153 153
No Information 143 143
Insufficient Information 127 127
Unspecified Infection 107 107
Blood Loss 105 105
No Code Available 67 67
Death 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Foreign Body In Patient 40 40
Peritonitis 33 33
Air Embolism 32 33
Device Embedded In Tissue or Plaque 32 32
Bacterial Infection 31 31
Thrombosis/Thrombus 30 30
Fever 27 27
Injury 27 27
Pain 26 26
Renal Failure 19 19
Sepsis 18 18
Exsanguination 18 18
Cardiac Arrest 18 18
Purulent Discharge 16 16
Unintended Radiation Exposure 16 16
Hematoma 14 14
Skin Erosion 13 13
Thrombosis 12 12
Staphylococcus Aureus 12 12
Low Blood Pressure/ Hypotension 11 11
Thrombus 11 11
Swelling 10 10
Cardiac Perforation 10 10
Host-Tissue Reaction 10 10
Chest Pain 9 9
Failure of Implant 9 9
Patient Problem/Medical Problem 9 9
Tissue Damage 9 9
Perforation of Vessels 8 8
Chills 7 7
Loss of consciousness 7 7
Erythema 7 7
Drug Resistant Bacterial Infection 7 7
Embolism/Embolus 6 6
Dyspnea 6 7
Abdominal Pain 6 6
Perforation 6 6
Shock 6 6
Vomiting 5 5
Cardiac Tamponade 5 5
Low Oxygen Saturation 5 5
Complaint, Ill-Defined 5 5
Septic Shock 5 5
Respiratory Distress 5 5
High Blood Pressure/ Hypertension 5 5
Swelling/ Edema 5 5
Nausea 4 4
Cardiopulmonary Arrest 4 4
Fluid Discharge 4 4
Discomfort 4 4
Confusion/ Disorientation 4 4
Discharge 4 4
Stenosis 4 4
Renal Disease, End Stage 4 4
Skin Irritation 3 3
Great Vessel Perforation 3 3
Distress 3 3
Test Result 3 3
Radiation Exposure, Unintended 3 3
Post Operative Wound Infection 3 3
Erosion 3 3
Bradycardia 3 3
Fistula 3 3
Inflammation 3 3
Itching Sensation 3 3
Hypersensitivity/Allergic reaction 3 3
Pneumonia 3 3
Unspecified Tissue Injury 3 3
Pericardial Effusion 3 3
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Cancer 2 2
Paralysis 2 2
Infiltration into Tissue 2 2
Rash 2 2
Seizures 2 2
Hypoxia 2 2
Laceration(s) 2 2
Occlusion 2 2
Cyanosis 2 2
Extravasation 2 2
Fatigue 2 2
Encephalopathy 2 2
Bruise/Contusion 2 2
Stroke/CVA 2 2
Anemia 2 2
Atrial Fibrillation 2 2
Pulmonary Embolism 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Jan-12-2012
2 Angiodynamics, Inc. II Jan-11-2012
3 Angiodynamics, Inc. II Jun-04-2010
4 Argon Medical Devices, Inc II Sep-24-2014
5 Arrow International Inc II Jan-22-2015
6 Arrow International Inc I Jul-30-2011
7 Bard Access Systems III Aug-27-2012
8 Bard Peripheral Vascular Inc II Jun-03-2020
9 Bard Peripheral Vascular Inc II Aug-26-2019
10 Covidien LLC II Jul-01-2015
11 Covidien LP II Sep-25-2023
12 Covidien Llc I Jul-07-2022
13 Covidien, LP II Aug-27-2021
14 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
15 Medical Components, Inc dba MedComp II Sep-06-2020
16 Medical Components, Inc dba MedComp II Mar-30-2015
17 Medical Components, Inc dba MedComp II Sep-04-2014
18 Medical Components, Inc dba MedComp II Jun-28-2011
19 Medical Components, Inc dba MedComp II Nov-10-2009
20 R4 Vascular Inc II Jun-06-2011
21 Spire Biomedical, Inc. II Nov-17-2009
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