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TPLC
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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 Code
PFH
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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