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U.S. Department of Health and Human Services

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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 27 27
Restricted Flow rate 23 23
Obstruction of Flow 20 20
Adverse Event Without Identified Device or Use Problem 17 17
Appropriate Term/Code Not Available 17 17
Fluid/Blood Leak 12 12
Difficult to Flush 11 11
Failure to Infuse 11 11
Blocked Connection 10 10
Device Dislodged or Dislocated 5 5
Improper or Incorrect Procedure or Method 5 5
Reflux within Device 5 5
Fracture 4 4
Air/Gas in Device 3 3
Device Tipped Over 3 3
Expulsion 2 2
Migration 2 2
Loss of or Failure to Bond 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Device Inoperable 1 1
Backflow 1 1
Device Appears to Trigger Rejection 1 1
Complete Blockage 1 1
Disconnection 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Flushing Problem 1 1
Material Split, Cut or Torn 1 1
Illegible Information 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Consequences Or Impact To Patient 43 43
Unspecified Infection 7 7
Pain 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Skin Erosion 7 7
Hemorrhage/Bleeding 4 4
Sepsis 4 4
No Known Impact Or Consequence To Patient 4 4
Swelling 2 2
Hematoma 2 2
Erythema 2 2
Thrombus 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Numbness 1 1
Headache 1 1
Injury 1 1
Bruise/Contusion 1 1
Obstruction/Occlusion 1 1
Blurred Vision 1 1
Thrombosis/Thrombus 1 1
Chills 1 1
Death 1 1
Extravasation 1 1
Palpitations 1 1
Pocket Erosion 1 1
Anxiety 1 1
Weakness 1 1
Reaction 1 1
Burning Sensation 1 1
Scar Tissue 1 1

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