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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device midline catheter
Definition The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Product CodePND
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 59 59
2020 93 93
2021 86 86
2022 178 178
2023 140 140
2024 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 152 152
Material Deformation 106 106
Adverse Event Without Identified Device or Use Problem 56 56
Break 52 52
Material Frayed 51 51
Defective Component 24 24
Difficult or Delayed Separation 22 22
Material Separation 18 18
Failure to Infuse 14 14
Detachment of Device or Device Component 13 13
Physical Resistance/Sticking 11 11
Leak/Splash 9 9
Activation Problem 7 7
Material Split, Cut or Torn 7 7
Difficult to Insert 6 6
Entrapment of Device 6 6
Improper or Incorrect Procedure or Method 6 6
Difficult to Remove 6 6
Crack 5 5
Material Twisted/Bent 5 5
Component Misassembled 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Obstruction of Flow 5 5
Failure to Advance 3 3
Patient-Device Incompatibility 3 3
Device Markings/Labelling Problem 3 3
Device Dislodged or Dislocated 3 3
Unsealed Device Packaging 3 3
Component Missing 3 3
Tear, Rip or Hole in Device Packaging 2 2
Suction Problem 2 2
Unraveled Material 2 2
Misassembled 2 2
Coagulation in Device or Device Ingredient 2 2
Backflow 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Premature Separation 2 2
Material Protrusion/Extrusion 1 1
Material Too Soft/Flexible 1 1
Infusion or Flow Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Loss of or Failure to Bond 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Migration or Expulsion of Device 1 1
Flushing Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Stretched 1 1
Use of Device Problem 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 289 289
No Consequences Or Impact To Patient 104 104
Insufficient Information 42 42
Foreign Body In Patient 40 40
Swelling/ Edema 25 25
Erythema 24 24
No Known Impact Or Consequence To Patient 20 20
Thrombosis/Thrombus 15 15
Pain 14 14
Thrombus 8 8
Tissue Damage 5 5
Device Embedded In Tissue or Plaque 5 5
Blood Loss 5 5
Laceration(s) 5 5
Extravasation 5 5
Hemorrhage/Bleeding 4 4
Perforation 4 4
No Patient Involvement 4 4
Needle Stick/Puncture 4 4
Discomfort 3 3
Unspecified Infection 3 3
Infiltration into Tissue 2 2
Inflammation 2 2
Thrombosis 2 2
Phlebitis 2 2
Hypersensitivity/Allergic reaction 2 2
Hematoma 2 2
Arrhythmia 2 2
Skin Tears 2 2
Foreign Body Embolism 2 2
Ulcer 2 2
Unspecified Tissue Injury 2 2
Subcutaneous Nodule 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Confusion/ Disorientation 1 1
Numbness 1 1
Coma 1 1
Low Oxygen Saturation 1 1
Low Cardiac Output 1 1
Anaphylactoid 1 1
Exposure to Body Fluids 1 1
Endocarditis 1 1
Abscess 1 1
Air Embolism 1 1
Rash 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Oct-19-2022
2 Arrow International Inc II Jun-16-2019
3 Becton Dickinson & Company II Oct-23-2020
4 Becton Dickinson & Company II May-09-2020
5 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Nov-27-2019
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