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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

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 328 328
Break 299 299
Fluid/Blood Leak 244 244
Fracture 209 209
Material Puncture/Hole 204 204
Material Deformation 182 182
Crack 142 142
Detachment of Device or Device Component 123 123
Leak/Splash 117 117
Deformation Due to Compressive Stress 81 81
Material Integrity Problem 79 79
Material Opacification 72 72
Stretched 63 63
Device Dislodged or Dislocated 63 63
Obstruction of Flow 62 62
Difficult to Remove 56 56
Material Separation 53 53
Component Missing 48 48
Material Protrusion/Extrusion 45 45
Adverse Event Without Identified Device or Use Problem 45 45
Insufficient Flow or Under Infusion 42 42
Kinked 41 41
Material Frayed 40 40
Material Discolored 38 38
Air/Gas in Device 38 38
Appropriate Term/Code Not Available 37 37
Restricted Flow rate 35 35
Disconnection 34 34
Loosening of Implant Not Related to Bone-Ingrowth 34 34
Infusion or Flow Problem 33 33
Expulsion 33 33
Migration or Expulsion of Device 33 33
Product Quality Problem 32 32
Suction Problem 30 30
Failure To Adhere Or Bond 26 26
Failure to Advance 21 21
Collapse 19 19
Tear, Rip or Hole in Device Packaging 18 18
Material Twisted/Bent 18 18
Packaging Problem 17 17
Material Split, Cut or Torn 17 17
Insufficient Information 16 16
Migration 16 16
Loss of or Failure to Bond 16 16
Material Fragmentation 16 16
Connection Problem 15 15
Contamination /Decontamination Problem 13 13
Occlusion Within Device 12 12
Unsealed Device Packaging 12 12
Difficult to Insert 11 11
Component Incompatible 11 11
Physical Resistance/Sticking 11 11
Difficult or Delayed Separation 10 10
Device Markings/Labelling Problem 10 10
Failure to Infuse 10 10
Material Rupture 10 10
Hole In Material 9 9
Gas/Air Leak 9 9
Device Contamination with Chemical or Other Material 8 8
Unraveled Material 8 8
Melted 8 8
Misconnection 7 7
Nonstandard Device 7 7
Reflux within Device 7 7
Improper or Incorrect Procedure or Method 7 7
Ambient Temperature Problem 7 7
Separation Failure 7 7
Improper Flow or Infusion 6 6
No Fail-Safe Mechanism 6 6
Component Misassembled 6 6
Use of Device Problem 6 6
Sticking 6 6
Device Damaged Prior to Use 6 6
Loose or Intermittent Connection 6 6
Difficult to Flush 6 6
Detachment Of Device Component 6 6
Difficult to Advance 5 5
Device Operates Differently Than Expected 5 5
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
Dent in Material 3 3
Fitting Problem 3 3
Peeled/Delaminated 3 3
No Flow 3 3
Operating System Becomes Nonfunctional 3 3
Defective Device 3 3
Protective Measures Problem 3 3
Premature Separation 3 3
Inaccurate Information 2 2
Suction Failure 2 2
Wireless Communication Problem 2 2
Malposition of Device 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Appears to Trigger Rejection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1030 1030
No Consequences Or Impact To Patient 868 868
No Known Impact Or Consequence To Patient 219 219
No Patient Involvement 173 173
Insufficient Information 73 73
Blood Loss 50 50
Hemorrhage/Bleeding 46 46
No Information 38 38
Unspecified Infection 37 37
Death 26 26
Foreign Body In Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Injury 22 22
Thrombosis/Thrombus 18 18
Device Embedded In Tissue or Plaque 17 17
Air Embolism 14 14
Exsanguination 12 12
Skin Erosion 12 12
No Code Available 12 12
Bacterial Infection 11 11
Unintended Radiation Exposure 11 11
Fever 9 9
Cardiac Arrest 9 9
Hematoma 8 8
Embolism/Embolus 5 5
Pain 5 5
Drug Resistant Bacterial Infection 4 4
Cardiac Tamponade 4 4
Sepsis 4 4
Perforation of Vessels 4 4
Shock 4 4
Swelling/ Edema 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Renal Failure 3 3
Loss of consciousness 3 3
Perforation 3 3
Failure of Implant 3 3
Radiation Exposure, Unintended 3 3
Respiratory Distress 3 3
Distress 3 3
Stenosis 2 2
Impaired Healing 2 2
Cardiac Perforation 2 2
Chest Pain 2 2
Tissue Breakdown 2 2
Thrombus 2 2
Fluid Discharge 2 2
Swelling 2 2
Chills 2 2
Septic Shock 2 2
Low Blood Pressure/ Hypotension 2 2
Dyspnea 2 2
Patient Problem/Medical Problem 2 2
Not Applicable 1 1
Hypoxia 1 1
Heart Block 1 1
Respiratory Insufficiency 1 1
Great Vessel Perforation 1 1
Diminished Pulse Pressure 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Hemoptysis 1 1
Endocarditis 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Hypovolemia 1 1
Pulmonary Embolism 1 1
Low Oxygen Saturation 1 1
Osteomyelitis 1 1
Infiltration into Tissue 1 1
High Blood Pressure/ Hypertension 1 1
Anemia 1 1
Cardiopulmonary Arrest 1 1
Encephalopathy 1 1
Extravasation 1 1
Hemorrhagic Stroke 1 1
Embolism 1 1
Embolus 1 1
Hemothorax 1 1
Pneumonia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Post Operative Wound Infection 1 1
Atrial Fibrillation 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 Llc I Jul-07-2022
4 Covidien, LP II Aug-27-2021
5 MARVAO MEDICAL DEVICES LTD. II Jun-01-2021
6 Medical Components, Inc dba MedComp II Sep-06-2020
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