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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 230 230

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 768 768
Break 646 646
Crack 476 476
Leak/Splash 435 435
Fracture 433 433
Defective Component 340 340
Material Puncture/Hole 276 276
Material Deformation 234 234
Detachment of Device or Device Component 169 169
Deformation Due to Compressive Stress 159 159
Hole In Material 130 130
Material Separation 121 121
Adverse Event Without Identified Device or Use Problem 111 111
Material Integrity Problem 105 105
Device Dislodged or Dislocated 102 102
Device Operates Differently Than Expected 102 102
Stretched 101 101
Difficult to Remove 101 101
Obstruction of Flow 98 98
Material Opacification 91 91
Migration or Expulsion of Device 89 89
Restricted Flow rate 83 83
Kinked 82 82
Detachment Of Device Component 81 81
Insufficient Flow or Under Infusion 76 76
Insufficient Information 73 73
Air Leak 65 65
Material Protrusion/Extrusion 63 63
Air/Gas in Device 62 62
Appropriate Term/Code Not Available 61 61
Disconnection 60 60
Material Discolored 58 58
Material Frayed 51 51
Component Missing 51 51
Expulsion 49 49
Occlusion Within Device 49 49
Loosening of Implant Not Related to Bone-Ingrowth 48 48
Infusion or Flow Problem 47 47
Failure to Advance 47 47
Product Quality Problem 46 46
Suction Problem 40 40
Migration 37 37
Connection Problem 36 36
Material Fragmentation 35 35
Material Twisted/Bent 34 34
Unraveled Material 33 33
Collapse 33 33
Difficult to Insert 33 33
Packaging Problem 30 30
Physical Resistance/Sticking 29 29
Failure To Adhere Or Bond 28 28
Sticking 28 28
Tear, Rip or Hole in Device Packaging 25 25
Gas/Air Leak 24 24
Split 23 23
Material Split, Cut or Torn 23 23
Difficult or Delayed Separation 22 22
Improper or Incorrect Procedure or Method 22 22
Loss of or Failure to Bond 22 22
Unsealed Device Packaging 20 20
Material Rupture 19 19
Bent 19 19
Malposition of Device 19 19
Improper Flow or Infusion 18 18
Torn Material 17 17
Contamination /Decontamination Problem 17 17
Component Falling 17 17
Loose or Intermittent Connection 17 17
Partial Blockage 15 15
Device Markings/Labelling Problem 15 15
Device Damaged Prior to Use 15 15
Device Contamination with Chemical or Other Material 14 14
Contamination 14 14
No Flow 14 14
Difficult to Flush 13 13
Human-Device Interface Problem 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
Scratched Material 9 9
Difficult to Advance 9 9
Fitting Problem 9 9
Peeled/Delaminated 9 9
Inaccurate Flow Rate 9 9
Entrapment of Device 8 8
Complete Blockage 8 8
Nonstandard Device 8 8
Device Inoperable 8 8
Cut In Material 8 8
Aspiration Issue 8 8
Component Misassembled 8 8
Unintended Movement 7 7
No Fail-Safe Mechanism 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1657 1657
No Consequences Or Impact To Patient 1295 1295
No Known Impact Or Consequence To Patient 1273 1273
No Patient Involvement 229 229
Hemorrhage/Bleeding 155 155
No Information 143 143
Insufficient Information 134 134
Unspecified Infection 109 109
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 33 34
Device Embedded In Tissue or Plaque 33 33
Thrombosis/Thrombus 31 31
Bacterial Infection 31 31
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 15 15
Skin Erosion 13 13
Thrombosis 12 12
Staphylococcus Aureus 12 12
Low Blood Pressure/ Hypotension 12 12
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
Erythema 8 8
Chills 7 7
Loss of consciousness 7 7
Drug Resistant Bacterial Infection 7 7
Swelling/ Edema 6 6
Embolism/Embolus 6 6
Shock 6 6
Dyspnea 6 7
Abdominal Pain 6 6
Perforation 6 6
Septic Shock 5 5
Respiratory Distress 5 5
High Blood Pressure/ Hypertension 5 5
Vomiting 5 5
Cardiac Tamponade 5 5
Low Oxygen Saturation 5 5
Complaint, Ill-Defined 5 5
Fluid Discharge 4 4
Discomfort 4 4
Confusion/ Disorientation 4 4
Discharge 4 4
Stenosis 4 4
Renal Disease, End Stage 4 4
Nausea 4 4
Cardiopulmonary Arrest 4 4
Erosion 3 3
Bradycardia 3 3
Fistula 3 3
Inflammation 3 3
Itching Sensation 3 3
Hypersensitivity/Allergic reaction 3 3
Pneumonia 3 3
Skin Irritation 3 3
Great Vessel Perforation 3 3
Distress 3 3
Respiratory Failure 3 3
Test Result 3 3
Radiation Exposure, Unintended 3 3
Post Operative Wound Infection 3 3
Unspecified Tissue Injury 3 3
Pericardial Effusion 3 3
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Cancer 2 2
Tissue Breakdown 2 2
Fungal Infection 2 2
Obstruction/Occlusion 2 2
Burning Sensation 2 2
Tachycardia 2 2
Urinary Tract Infection 2 2
Therapeutic Response, Increased 2 2
Pressure Sores 2 2
Malaise 2 2
Impaired Healing 2 2
Hypovolemia 2 2
Rupture 2 2
Paralysis 2 2
Infiltration into Tissue 2 2
Rash 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Jan-12-2012
2 Angiodynamics, Inc. II May-03-2024
3 Angiodynamics, Inc. II Jan-11-2012
4 Angiodynamics, Inc. II Jun-04-2010
5 Argon Medical Devices, Inc II Sep-24-2014
6 Arrow International Inc II Jan-22-2015
7 Arrow International Inc I Jul-30-2011
8 Bard Access Systems III Aug-27-2012
9 Bard Peripheral Vascular Inc II Jun-03-2020
10 Bard Peripheral Vascular Inc II Aug-26-2019
11 Covidien LLC II Jul-01-2015
12 Covidien LP II Apr-24-2024
13 Covidien LP II Sep-25-2023
14 Covidien Llc I Jul-07-2022
15 Covidien, LP II Aug-27-2021
16 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
17 Medical Components, Inc dba MedComp II Sep-06-2020
18 Medical Components, Inc dba MedComp II Mar-30-2015
19 Medical Components, Inc dba MedComp II Sep-04-2014
20 Medical Components, Inc dba MedComp II Jun-28-2011
21 Medical Components, Inc dba MedComp II Nov-10-2009
22 R4 Vascular Inc II Jun-06-2011
23 Spire Biomedical, Inc. II Nov-17-2009
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