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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 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 161 161
Material Deformation 82 82
Break 80 80
Difficult to Remove 70 70
Material Frayed 67 67
Deformation Due to Compressive Stress 66 66
Product Quality Problem 59 59
Fluid/Blood Leak 54 54
Physical Resistance/Sticking 36 36
Crack 35 35
Unraveled Material 35 35
Obstruction of Flow 27 27
Material Twisted/Bent 26 26
Leak/Splash 25 25
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 15 15
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
Device Damaged Prior to Use 5 5
Failure to Advance 4 4
Loose or Intermittent Connection 4 4
Insufficient Information 4 4
Suction Failure 3 3
Separation Problem 3 3
Mechanical Problem 3 3
Unintended Ejection 3 3
Material Fragmentation 3 3
Malposition of Device 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
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 519 519
No Consequences Or Impact To Patient 180 180
Insufficient Information 73 73
No Patient Involvement 29 29
No Known Impact Or Consequence To Patient 24 24
No Information 20 20
Hemorrhage/Bleeding 17 17
Needle Stick/Puncture 14 14
Foreign Body In Patient 14 14
Blood Loss 13 13
No Code Available 8 8
Unintended Radiation Exposure 8 8
Hematoma 7 7
Radiation Exposure, Unintended 6 6
Air Embolism 6 6
Low Blood Pressure/ Hypotension 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling/ Edema 4 4
Device Embedded In Tissue or Plaque 3 3
Death 3 3
Failure of Implant 3 3
Unspecified Infection 2 2
Headache 2 2
Erythema 2 2
Exsanguination 2 2
Bradycardia 2 2
Cardiac Arrest 2 2
Low Oxygen Saturation 2 2
Decreased Respiratory Rate 2 2
Skin Tears 2 2
Pain 2 2
Loss of consciousness 2 2
Neck Pain 1 1
Alteration in Body Temperature 1 1
Thrombosis/Thrombus 1 1
Asystole 1 1
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
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Fever 1 1
Abrasion 1 1
Hemothorax 1 1
Ischemia 1 1
Laceration(s) 1 1
Overdose 1 1

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