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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 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 167 167
Material Deformation 87 87
Break 83 83
Material Frayed 74 74
Difficult to Remove 71 71
Deformation Due to Compressive Stress 66 66
Product Quality Problem 63 63
Fluid/Blood Leak 58 58
Unraveled Material 40 40
Physical Resistance/Sticking 38 38
Crack 37 37
Material Twisted/Bent 32 32
Obstruction of Flow 29 29
Leak/Splash 27 27
Material Separation 21 21
Migration or Expulsion of Device 20 20
Component Incompatible 19 19
Detachment of Device or Device Component 18 18
Defective Component 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Migration 16 16
Material Integrity Problem 15 15
Infusion or Flow Problem 12 12
Disconnection 12 12
Device Markings/Labelling Problem 9 9
Failure to Infuse 9 9
Insufficient Flow or Under Infusion 9 9
Contamination /Decontamination Problem 9 9
Difficult to Advance 8 8
Gas/Air Leak 8 8
Difficult to Insert 7 7
Device Damaged Prior to Use 6 6
Device Handling Problem 6 6
Material Split, Cut or Torn 5 5
Air/Gas in Device 5 5
Insufficient Information 5 5
Failure to Advance 4 4
Fitting Problem 4 4
Material Fragmentation 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 3 3
Unintended Ejection 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
Misassembled 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
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
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 560 560
No Consequences Or Impact To Patient 180 180
Insufficient Information 78 78
No Patient Involvement 29 29
No Known Impact Or Consequence To Patient 24 24
No Information 20 20
Hemorrhage/Bleeding 20 20
Foreign Body In Patient 15 15
Needle Stick/Puncture 14 14
Blood Loss 13 13
Unintended Radiation Exposure 8 8
No Code Available 8 8
Hematoma 8 8
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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