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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 26 26
Restricted Flow rate 23 23
Obstruction of Flow 18 18
Appropriate Term/Code Not Available 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Fluid/Blood Leak 11 11
Failure to Infuse 11 11
Difficult to Flush 10 10
Blocked Connection 10 10
Device Dislodged or Dislocated 5 5
Reflux within Device 5 5
Fracture 4 4
Device Tipped Over 3 3
Improper or Incorrect Procedure or Method 3 3
Migration 2 2
Expulsion 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
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
Material Split, Cut or Torn 1 1
Illegible Information 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
No Consequences Or Impact To Patient 43 43
Unspecified Infection 7 7
Pain 7 7
Skin Erosion 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Known Impact Or Consequence To Patient 4 4
Sepsis 4 4
Hemorrhage/Bleeding 4 4
Erythema 2 2
Swelling 2 2
Hematoma 2 2
Anxiety 1 1
Injury 1 1
Reaction 1 1
Numbness 1 1
Obstruction/Occlusion 1 1
Palpitations 1 1
Thrombus 1 1
Blurred Vision 1 1
Weakness 1 1
Burning Sensation 1 1
Chills 1 1
Pocket Erosion 1 1
Scar Tissue 1 1
Extravasation 1 1
Fever 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Bruise/Contusion 1 1
Death 1 1

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