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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
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 2
MARVAO MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS INC. (MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT - KIT 1
PRISTINE ACCESS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 462 462
2019 645 645
2020 401 401
2021 523 523
2022 610 610
2023 350 350

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 334 334
Break 332 332
Fluid/Blood Leak 299 299
Fracture 285 285
Material Puncture/Hole 245 245
Material Deformation 190 190
Crack 166 166
Leak/Splash 133 133
Detachment of Device or Device Component 130 130
Deformation Due to Compressive Stress 112 112
Material Integrity Problem 85 85
Obstruction of Flow 82 82
Material Opacification 77 77
Material Separation 71 71
Stretched 71 71
Difficult to Remove 63 63
Device Dislodged or Dislocated 63 63
Adverse Event Without Identified Device or Use Problem 56 56
Material Protrusion/Extrusion 50 50
Component Missing 49 49
Insufficient Flow or Under Infusion 49 49
Air/Gas in Device 48 48
Material Discolored 44 44
Loosening of Implant Not Related to Bone-Ingrowth 43 43
Expulsion 43 43
Kinked 41 41
Restricted Flow rate 40 40
Material Frayed 40 40
Product Quality Problem 40 40
Appropriate Term/Code Not Available 38 38
Disconnection 37 37
Migration or Expulsion of Device 35 35
Infusion or Flow Problem 35 35
Suction Problem 34 34
Failure to Advance 29 29
Failure To Adhere Or Bond 26 26
Material Twisted/Bent 25 25
Migration 25 25
Material Fragmentation 21 21
Collapse 20 20
Insufficient Information 20 20
Material Split, Cut or Torn 20 20
Gas/Air Leak 19 19
Tear, Rip or Hole in Device Packaging 18 18
Packaging Problem 17 17
Loss of or Failure to Bond 17 17
Difficult to Insert 17 17
Physical Resistance/Sticking 16 16
Connection Problem 16 16
Contamination /Decontamination Problem 14 14
Device Markings/Labelling Problem 14 14
Difficult or Delayed Separation 13 13
Unsealed Device Packaging 13 13
Occlusion Within Device 12 12
Component Incompatible 11 11
Separation Failure 11 11
Failure to Infuse 10 10
Unraveled Material 10 10
Material Rupture 10 10
Hole In Material 9 9
Difficult to Flush 8 8
Melted 8 8
Device Contamination with Chemical or Other Material 8 8
Ambient Temperature Problem 7 7
Reflux within Device 7 7
Misconnection 7 7
Nonstandard Device 7 7
Improper or Incorrect Procedure or Method 7 7
Device Damaged Prior to Use 7 7
Use of Device Problem 6 6
Sticking 6 6
Loose or Intermittent Connection 6 6
Detachment Of Device Component 6 6
Difficult to Advance 6 6
No Fail-Safe Mechanism 6 6
Component Misassembled 6 6
Improper Flow or Infusion 6 6
Device Operates Differently Than Expected 5 5
Defective Device 4 4
Human-Device Interface Problem 4 4
Contamination 4 4
Bent 4 4
Burst Container or Vessel 3 3
Complete Blockage 3 3
Corroded 3 3
Entrapment of Device 3 3
Fitting Problem 3 3
Peeled/Delaminated 3 3
No Flow 3 3
Dent in Material 3 3
Operating System Becomes Nonfunctional 3 3
Protective Measures Problem 3 3
Premature Separation 3 3
Inaccurate Information 2 2
Suction Failure 2 2
Separation Problem 2 2
Wireless Communication Problem 2 2
Patient-Device Incompatibility 2 2
Malposition of Device 2 2
Device Misassembled During Manufacturing /Shipping 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1317 1317
No Consequences Or Impact To Patient 868 868
No Known Impact Or Consequence To Patient 219 219
No Patient Involvement 173 173
Insufficient Information 98 98
Hemorrhage/Bleeding 58 58
Blood Loss 50 50
Unspecified Infection 42 42
No Information 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Death 26 26
Foreign Body In Patient 26 26
Thrombosis/Thrombus 23 23
Injury 22 22
Air Embolism 18 18
Device Embedded In Tissue or Plaque 17 17
Unintended Radiation Exposure 15 15
No Code Available 12 12
Skin Erosion 12 12
Bacterial Infection 12 12
Cardiac Arrest 12 12
Exsanguination 12 12
Fever 9 9
Hematoma 9 9
Pain 7 7
Loss of consciousness 6 6
Embolism/Embolus 6 6
Swelling/ Edema 5 5
Perforation of Vessels 5 5
Sepsis 5 5
Shock 5 5
Low Blood Pressure/ Hypotension 5 5
Cardiac Tamponade 4 4
Drug Resistant Bacterial Infection 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Distress 3 3
Failure of Implant 3 3
Radiation Exposure, Unintended 3 3
Perforation 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Dyspnea 3 3
Chest Pain 2 2
High Blood Pressure/ Hypertension 2 2
Patient Problem/Medical Problem 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Impaired Healing 2 2
Cardiac Perforation 2 2
Confusion/ Disorientation 2 2
Septic Shock 2 2
Swelling 2 2
Thrombus 2 2
Peritonitis 2 2
Stenosis 2 2
Chills 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Osteomyelitis 1 1
Hemorrhagic Stroke 1 1
Heart Block 1 1
Pericarditis 1 1
Aspiration Pneumonitis 1 1
Dizziness 1 1
Hypovolemia 1 1
Vomiting 1 1
Great Vessel Perforation 1 1
Lethargy 1 1
Diminished Pulse Pressure 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Fibrosis 1 1
Not Applicable 1 1
Pulmonary Embolism 1 1
Hemothorax 1 1
Hypersensitivity/Allergic reaction 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Pneumonia 1 1
Hypoxia 1 1
Paralysis 1 1
Cyanosis 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Anemia 1 1
Atrial Fibrillation 1 1
Embolism 1 1
Embolus 1 1
Encephalopathy 1 1
Endocarditis 1 1
Hemoptysis 1 1
Extravasation 1 1
Fatigue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-03-2020
2 Bard Peripheral Vascular Inc II Aug-26-2019
3 Covidien LP II Sep-25-2023
4 Covidien Llc I Jul-07-2022
5 Covidien, LP II Aug-27-2021
6 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
7 Medical Components, Inc dba MedComp II Sep-06-2020
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