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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device venous window needle guide
Definition For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.
Product CodePFH
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
VITAL ACCESS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2016 7 7
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Difficult to Insert 2 2
Appropriate Term/Code Not Available 2 2
Insufficient Flow or Under Infusion 1 1
Obstruction of Flow 1 1
Contamination 1 1
Filling Problem 1 1
Gradient Increase 1 1
Insufficient Information 1 1
Improper Flow or Infusion 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 5 5
Purulent Discharge 3 3
Erythema 3 3
Staphylococcus Aureus 3 3
Swelling 3 3
Hematoma 3 3
Post Operative Wound Infection 2 2
Pain 2 2
Pneumonia 1 1
Pocket Erosion 1 1
Skin Discoloration 1 1
Therapeutic Effects, Unexpected 1 1
Rupture 1 1
Discharge 1 1
Stenosis 1 1
Reaction 1 1
Skin Inflammation 1 1
Fistula 1 1
Hearing Impairment 1 1
Necrosis 1 1
Occlusion 1 1
Wound Dehiscence 1 1
Abscess 1 1
Bacterial Infection 1 1
Confusion/ Disorientation 1 1
Fluid Discharge 1 1

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