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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
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS INC. (MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE ACCESS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Fracture 347 347
Defective Component 309 309
Fluid/Blood Leak 293 293
Break 276 276
Material Puncture/Hole 263 263
Crack 165 165
Deformation Due to Compressive Stress 147 147
Material Deformation 144 144
Detachment of Device or Device Component 136 136
Leak/Splash 115 115
Stretched 94 94
Material Opacification 91 91
Material Separation 89 89
Material Integrity Problem 88 88
Obstruction of Flow 86 86
Difficult to Remove 71 71
Restricted Flow rate 69 69
Adverse Event Without Identified Device or Use Problem 67 67
Material Protrusion/Extrusion 61 61
Air/Gas in Device 61 61
Insufficient Flow or Under Infusion 61 61
Material Discolored 51 51
Expulsion 48 48
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Component Missing 42 42
Product Quality Problem 39 39
Suction Problem 38 38
Migration 37 37
Failure to Advance 32 32
Device Dislodged or Dislocated 31 31
Disconnection 30 30
Material Frayed 29 29
Infusion or Flow Problem 29 29
Migration or Expulsion of Device 28 28
Material Twisted/Bent 26 26
Physical Resistance/Sticking 26 26
Difficult to Insert 24 24
Material Fragmentation 23 23
Collapse 20 20
Loss of or Failure to Bond 20 20
Appropriate Term/Code Not Available 20 20
Material Split, Cut or Torn 19 19
Packaging Problem 19 19
Gas/Air Leak 18 18
Unsealed Device Packaging 18 18
Insufficient Information 17 17
Difficult or Delayed Separation 17 17
Contamination /Decontamination Problem 16 16
Tear, Rip or Hole in Device Packaging 15 15
Device Markings/Labelling Problem 14 14
Unraveled Material 14 14
Separation Failure 12 12
Improper or Incorrect Procedure or Method 12 12
Component Incompatible 11 11
Difficult to Flush 10 10
Melted 10 10
Device Damaged Prior to Use 10 10
Reflux within Device 10 10
Connection Problem 10 10
Nonstandard Device 8 8
Material Rupture 8 8
Failure to Infuse 8 8
Loose or Intermittent Connection 7 7
Misconnection 7 7
Difficult to Advance 7 7
Improper Flow or Infusion 7 7
Ambient Temperature Problem 7 7
Component Misassembled 7 7
Separation Problem 7 7
Device Contamination with Chemical or Other Material 6 6
No Fail-Safe Mechanism 6 6
Moisture Damage 6 6
Entrapment of Device 5 5
Use of Device Problem 5 5
Dent in Material 5 5
Device Appears to Trigger Rejection 5 5
Malposition of Device 4 4
Contamination 4 4
Backflow 4 4
Premature Separation 4 4
Incomplete or Inadequate Connection 3 3
No Flow 3 3
Operating System Becomes Nonfunctional 3 3
Complete Blockage 3 3
Fitting Problem 3 3
Peeled/Delaminated 3 3
Failure to Unfold or Unwrap 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Burst Container or Vessel 2 2
Biofilm coating in Device 2 2
Corroded 2 2
Degraded 2 2
Protective Measures Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Free or Unrestricted Flow 2 2
Difficult to Open or Remove Packaging Material 2 2
Suction Failure 2 2
Inaccurate Information 2 2
Wireless Communication Problem 2 2

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 593 593
No Patient Involvement 151 151
Insufficient Information 123 123
No Known Impact Or Consequence To Patient 116 116
Hemorrhage/Bleeding 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Unspecified Infection 41 41
Thrombosis/Thrombus 30 30
No Information 29 29
Blood Loss 25 25
Foreign Body In Patient 23 23
Injury 21 21
Air Embolism 19 19
Bacterial Infection 19 19
Device Embedded In Tissue or Plaque 17 17
Unintended Radiation Exposure 16 16
Death 14 14
Cardiac Arrest 11 11
Sepsis 11 11
Skin Erosion 11 11
Exsanguination 10 10
Fever 9 9
Hematoma 9 9
Failure of Implant 9 9
Pain 7 7
Drug Resistant Bacterial Infection 7 7
No Code Available 7 7
Embolism/Embolus 6 6
Swelling/ Edema 5 5
Low Blood Pressure/ Hypotension 5 5
Purulent Discharge 5 5
Perforation of Vessels 5 5
Loss of consciousness 5 5
Cardiac Tamponade 4 4
Peritonitis 4 4
Shock 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Distress 3 3
Dyspnea 3 3
Encephalopathy 2 2
Chest Pain 2 2
Impaired Healing 2 2
Cardiac Perforation 2 2
Confusion/ Disorientation 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Septic Shock 2 2
Urinary Tract Infection 2 2
Swelling 2 2
Stenosis 2 2
Chills 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Radiation Exposure, Unintended 2 2
Patient Problem/Medical Problem 1 1
Hemorrhagic Stroke 1 1
Fibrosis 1 1
Not Applicable 1 1
Osteomyelitis 1 1
Heart Block 1 1
Pericarditis 1 1
Aspiration Pneumonitis 1 1
Dizziness 1 1
Vomiting 1 1
Great Vessel Perforation 1 1
Hypovolemia 1 1
Thrombus 1 1
Thromboembolism 1 1
Hypervolemia 1 1
Lethargy 1 1
Abdominal Distention 1 1
Discomfort 1 1
Fungal Infection 1 1
Post Operative Wound Infection 1 1
Respiratory Failure 1 1
Cyanosis 1 1
Stroke/CVA 1 1
Bradycardia 1 1
Anemia 1 1
Atrial Fibrillation 1 1
Endocarditis 1 1
Erythema 1 1
Extravasation 1 1
Fatigue 1 1
Embolism 1 1
Hypoxia 1 1
Pulmonary Embolism 1 1
Hemoptysis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Paralysis 1 1
Perforation 1 1
Pneumonia 1 1
Local Reaction 1 1
Infiltration into Tissue 1 1
Laceration(s) 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 Apr-24-2024
4 Covidien LP II Sep-25-2023
5 Covidien Llc I Jul-07-2022
6 Covidien, LP II Aug-27-2021
7 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
8 Medical Components, Inc dba MedComp II Sep-06-2020
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