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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, hemodialysis, non-implanted
Product CodeMPB
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 119 119
2020 179 179
2021 192 192
2022 166 166
2023 204 204
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 166 166
Material Deformation 83 83
Break 81 81
Difficult to Remove 71 71
Material Frayed 70 70
Deformation Due to Compressive Stress 66 66
Product Quality Problem 61 61
Fluid/Blood Leak 55 55
Unraveled Material 36 36
Physical Resistance/Sticking 36 36
Crack 35 35
Obstruction of Flow 28 28
Material Twisted/Bent 27 27
Leak/Splash 26 26
Migration or Expulsion of Device 20 20
Material Separation 19 19
Component Incompatible 19 19
Detachment of Device or Device Component 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Defective Component 16 16
Migration 16 16
Material Integrity Problem 14 14
Infusion or Flow Problem 12 12
Disconnection 11 11
Device Markings/Labelling Problem 9 9
Failure to Infuse 9 9
Insufficient Flow or Under Infusion 9 9
Contamination /Decontamination Problem 8 8
Difficult to Advance 8 8
Gas/Air Leak 8 8
Difficult to Insert 7 7
Device Handling Problem 6 6
Air/Gas in Device 5 5
Material Split, Cut or Torn 5 5
Insufficient Information 5 5
Device Damaged Prior to Use 5 5
Failure to Advance 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 3 3
Unintended Ejection 3 3
Material Fragmentation 3 3
Malposition of Device 3 3
Suction Failure 3 3
Separation Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Suction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contamination with Chemical or Other Material 2 2
Device Dislodged or Dislocated 2 2
Mechanics Altered 2 2
Backflow 2 2
Entrapment of Device 2 2
Contamination 2 2
Complete Blockage 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Device Slipped 2 2
Retraction Problem 2 2
Use of Device Problem 1 1
Volume Accuracy Problem 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Nonstandard Device 1 1
Display or Visual Feedback Problem 1 1
Positioning Failure 1 1
Flushing Problem 1 1
Fracture 1 1
Packaging Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Pumping Problem 1 1
Expulsion 1 1
Device Damaged by Another Device 1 1
Dull, Blunt 1 1
Component Missing 1 1
Fitting Problem 1 1
Material Perforation 1 1
Biocompatibility 1 1
Failure to Disconnect 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Fail-Safe Did Not Operate 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 531 531
No Consequences Or Impact To Patient 180 180
Insufficient Information 76 76
No Patient Involvement 29 29
No Known Impact Or Consequence To Patient 24 24
No Information 20 20
Hemorrhage/Bleeding 18 18
Needle Stick/Puncture 14 14
Foreign Body In Patient 14 14
Blood Loss 13 13
Unintended Radiation Exposure 8 8
No Code Available 8 8
Hematoma 7 7
Air Embolism 6 6
Radiation Exposure, Unintended 6 6
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Low Blood Pressure/ Hypotension 4 4
Cardiac Arrest 3 3
Death 3 3
Failure of Implant 3 3
Device Embedded In Tissue or Plaque 3 3
Loss of consciousness 2 2
Unspecified Infection 2 2
Headache 2 2
Erythema 2 2
Exsanguination 2 2
Bradycardia 2 2
Low Oxygen Saturation 2 2
Decreased Respiratory Rate 2 2
Skin Tears 2 2
Pain 2 2
Perforation 1 1
Pneumonia 1 1
Pneumothorax 1 1
Rash 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Burning Sensation 1 1
Dizziness 1 1
Hypoxia 1 1
Peritonitis 1 1
Abrasion 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Fever 1 1
Hemothorax 1 1
Ischemia 1 1
Laceration(s) 1 1
Overdose 1 1
Neck Pain 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Asystole 1 1
Alteration in Body Temperature 1 1

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