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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 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 354 354
Defective Component 309 309
Fluid/Blood Leak 302 302
Break 276 276
Material Puncture/Hole 266 266
Crack 167 167
Deformation Due to Compressive Stress 156 156
Material Deformation 148 148
Detachment of Device or Device Component 141 141
Leak/Splash 121 121
Stretched 96 96
Material Separation 91 91
Material Opacification 91 91
Material Integrity Problem 90 90
Obstruction of Flow 88 88
Difficult to Remove 75 75
Restricted Flow rate 71 71
Adverse Event Without Identified Device or Use Problem 69 69
Air/Gas in Device 62 62
Material Protrusion/Extrusion 61 61
Insufficient Flow or Under Infusion 61 61
Material Discolored 52 52
Expulsion 48 48
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Component Missing 42 42
Product Quality Problem 40 40
Suction Problem 38 38
Migration 37 37
Failure to Advance 33 33
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
Physical Resistance/Sticking 27 27
Material Twisted/Bent 26 26
Difficult to Insert 24 24
Material Fragmentation 23 23
Packaging Problem 23 23
Collapse 22 22
Loss of or Failure to Bond 20 20
Appropriate Term/Code Not Available 20 20
Material Split, Cut or Torn 19 19
Gas/Air Leak 19 19
Difficult or Delayed Separation 18 18
Unsealed Device Packaging 18 18
Insufficient Information 17 17
Contamination /Decontamination Problem 16 16
Unraveled Material 16 16
Tear, Rip or Hole in Device Packaging 15 15
Device Markings/Labelling Problem 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
Difficult to Advance 8 8
Component Misassembled 8 8
Nonstandard Device 8 8
Material Rupture 8 8
Failure to Infuse 8 8
Loose or Intermittent Connection 7 7
Misconnection 7 7
Separation Problem 7 7
Improper Flow or Infusion 7 7
Ambient Temperature 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 6 6
Device Appears to Trigger Rejection 6 6
Use of Device Problem 5 5
Dent in Material 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 1621 1621
No Consequences Or Impact To Patient 593 593
No Patient Involvement 151 151
Insufficient Information 126 126
No Known Impact Or Consequence To Patient 116 116
Hemorrhage/Bleeding 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Unspecified Infection 42 42
Thrombosis/Thrombus 31 31
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
Hematoma 10 10
Fever 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 6 6
Low Blood Pressure/ Hypotension 5 5
Purulent Discharge 5 5
Perforation of Vessels 5 5
Loss of consciousness 5 5
Peritonitis 4 4
Cardiac Tamponade 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
Erythema 2 2
Chest Pain 2 2
Stenosis 2 2
Impaired Healing 2 2
Cardiac Perforation 2 2
Confusion/ Disorientation 2 2
Swelling 2 2
Septic Shock 2 2
Urinary Tract Infection 2 2
Chills 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Radiation Exposure, Unintended 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 1 1
Fibrosis 1 1
Not Applicable 1 1
Hemorrhagic Stroke 1 1
Heart Block 1 1
Pericarditis 1 1
Aspiration Pneumonitis 1 1
Osteomyelitis 1 1
Dizziness 1 1
Hypovolemia 1 1
Vomiting 1 1
Great Vessel Perforation 1 1
Thrombus 1 1
Lethargy 1 1
Abdominal Distention 1 1
Thromboembolism 1 1
Hypervolemia 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
Pulmonary Embolism 1 1
Endocarditis 1 1
Embolism 1 1
Hypoxia 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hemoptysis 1 1
Extravasation 1 1
Fatigue 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 Angiodynamics, Inc. II May-03-2024
2 Bard Peripheral Vascular Inc II Jun-03-2020
3 Bard Peripheral Vascular Inc II Aug-26-2019
4 Covidien LP II Apr-24-2024
5 Covidien LP II Sep-25-2023
6 Covidien Llc I Jul-07-2022
7 Covidien, LP II Aug-27-2021
8 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
9 Medical Components, Inc dba MedComp II Sep-06-2020
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