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TPLC - Total Product Life Cycle
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Device subcutaneous implanted apheresis port
Definition A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
Product CodePTD
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
NORFOLK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 15 15
2019 35 35
2020 18 18
2021 15 15
2022 11 11
2023 25 25
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 28 28
Restricted Flow rate 25 25
Obstruction of Flow 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Appropriate Term/Code Not Available 17 17
Fluid/Blood Leak 13 13
Difficult to Flush 12 12
Failure to Infuse 11 11
Blocked Connection 10 10
Reflux within Device 5 5
Device Dislodged or Dislocated 5 5
Improper or Incorrect Procedure or Method 5 5
Fracture 4 4
Device Appears to Trigger Rejection 4 4
Device Tipped Over 3 3
Expulsion 3 3
Air/Gas in Device 3 3
Material Puncture/Hole 2 2
Material Separation 2 2
Migration 2 2
Loss of or Failure to Bond 2 2
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Device Inoperable 1 1
Difficult to Open or Close 1 1
Disconnection 1 1
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Complete Blockage 1 1
Backflow 1 1
Illegible Information 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Flushing Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
No Consequences Or Impact To Patient 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Infection 8 8
Skin Erosion 8 8
Pain 8 8
Sepsis 4 4
No Known Impact Or Consequence To Patient 4 4
Hemorrhage/Bleeding 4 4
Hematoma 2 2
Thrombosis/Thrombus 2 2
Erythema 2 2
Swelling 2 2
High Blood Pressure/ Hypertension 1 1
Arrhythmia 1 1
Death 1 1
Obstruction/Occlusion 1 1
Palpitations 1 1
Fever 1 1
Weakness 1 1
Burning Sensation 1 1
Chills 1 1
Injury 1 1
Numbness 1 1
Scar Tissue 1 1
Reaction 1 1
Extravasation 1 1
Tachycardia 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Blurred Vision 1 1
Bacterial Infection 1 1
Headache 1 1
Pocket Erosion 1 1
Thrombus 1 1
Pulmonary Embolism 1 1
Bruise/Contusion 1 1

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