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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, fistula
Regulation Description Blood access device and accessories.
Product CodeFIE
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JMS NORTH AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 58 68
2024 14 14
2025 33 33
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Fluid/Blood Leak 18 18
Device Appears to Trigger Rejection 9 9
Patient Device Interaction Problem 8 8
Obstruction of Flow 6 6
Output Problem 6 6
Material Puncture/Hole 6 6
Detachment of Device or Device Component 4 4
Device Dislodged or Dislocated 4 4
Air/Gas in Device 3 3
Device Difficult to Setup or Prepare 3 3
Device Slipped 3 13
Difficult to Remove 2 2
Leak/Splash 2 2
Retraction Problem 2 2
Unstable 2 12
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Integrity Problem 2 2
Positioning Problem 1 1
No Audible Alarm 1 1
Material Fragmentation 1 1
Patient-Device Incompatibility 1 1
Insufficient Device Problem Information 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Fail-Safe Did Not Operate 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Partial Blockage 1 1
Mechanical Problem 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Blood Loss/Bleeding 54 54
Pain 16 16
Insufficient Information 15 15
Exposure to Body Fluids 13 13
Needle Stick/Puncture 8 18
Itching Sensation 7 7
Air Embolism 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 5 15
Rash 5 5
Thrombosis/Thrombus 3 3
Swelling/ Edema 3 3
Failure of Implant 2 2
Hematoma 2 2
Injection Site Reaction 2 2
Hypersensitivity/Allergic reaction 2 2
Loss of consciousness 2 2
Nausea 1 1
Device Embedded In Tissue or Plaque 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Skin Burning Sensation 1 1
Neck Pain 1 1
Contact Dermatitis 1 1
Dyspnea 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Tachycardia 1 1
Syncope/Fainting 1 1
Infiltration into Tissue 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Stenosis 1 1
Anaphylactic Shock 1 1
Skin Inflammation/ Irritation 1 1

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