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TPLC
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show TPLC since
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2024
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Device
needle, fistula
Product Code
FIE
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAIN MEDICAL EQUIPMENT (GUANGZHOU)CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
21
21
2020
3
3
2021
1
1
2022
1
1
2023
58
68
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
39
39
Fluid/Blood Leak
11
11
Device Dislodged or Dislocated
10
10
Output Problem
6
6
Detachment of Device or Device Component
5
5
Device Slipped
4
14
Leak/Splash
3
3
Device Difficult to Setup or Prepare
3
3
Unstable
2
12
Expulsion
2
2
Material Integrity Problem
2
2
Difficult to Remove
2
2
Break
2
2
Fail-Safe Did Not Operate
2
2
Dull, Blunt
1
1
Positioning Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
No Audible Alarm
1
1
Backflow
1
1
Component Missing
1
1
Partial Blockage
1
1
Material Separation
1
1
Appropriate Term/Code Not Available
1
1
Mechanical Problem
1
1
Physical Resistance/Sticking
1
1
Insufficient Information
1
1
Patient-Device Incompatibility
1
1
Device Appears to Trigger Rejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hemorrhage/Bleeding
41
41
Hemolysis
14
14
Insufficient Information
13
13
Pain
13
13
Blood Loss
6
6
Needle Stick/Puncture
6
16
Hypovolemia
4
4
Discomfort
3
13
Loss of consciousness
3
3
Failure of Implant
2
2
Low Blood Pressure/ Hypotension
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Impaired Healing
1
1
Syncope/Fainting
1
1
Death
1
1
Hypersensitivity/Allergic reaction
1
1
Diaphoresis
1
1
Nausea
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Exsanguination
1
1
Skin Discoloration
1
1
Post Operative Wound Infection
1
1
Cardiac Arrest
1
1
Neck Pain
1
1
Exposure to Body Fluids
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Bradycardia
1
1
Shock
1
1
Anaphylactic Shock
1
1
Stenosis
1
1
Tachycardia
1
1
Swelling/ Edema
1
1
Skin Tears
1
1
Infiltration into Tissue
1
1
Bruise/Contusion
1
1
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