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TPLC
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Device
device, intravascular catheter securement
Product Code
KMK
Regulation Number
880.5210
Device Class
1
Premarket Reviews
Manufacturer
Decision
INTERRAD MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
14
14
2021
33
33
2022
103
103
2023
140
140
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
154
154
Loss of or Failure to Bond
28
28
Misconnection
24
24
Adverse Event Without Identified Device or Use Problem
20
20
Break
9
9
Difficult or Delayed Positioning
8
8
Improper or Incorrect Procedure or Method
8
8
Device Dislodged or Dislocated
7
7
Defective Component
6
6
Leak/Splash
6
6
Disconnection
5
5
Patient Device Interaction Problem
5
5
Material Twisted/Bent
5
5
Component Misassembled
4
4
Fluid/Blood Leak
4
4
Contamination
4
4
Difficult to Remove
4
4
Material Separation
4
4
Nonstandard Device
3
3
Patient-Device Incompatibility
3
3
Contamination /Decontamination Problem
3
3
Component Missing
2
2
Tear, Rip or Hole in Device Packaging
2
2
Misassembled
2
2
Material Deformation
2
2
Flaked
2
2
Separation Problem
2
2
Difficult or Delayed Separation
1
1
Adhesive Too Strong
1
1
Material Split, Cut or Torn
1
1
Packaging Problem
1
1
Positioning Problem
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Activation Failure
1
1
Inadequate Instructions for Healthcare Professional
1
1
Crack
1
1
Mechanical Problem
1
1
Device Damaged Prior to Use
1
1
Difficult to Open or Close
1
1
Fail-Safe Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Free or Unrestricted Flow
1
1
Failure to Align
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
260
260
Insufficient Information
13
13
No Known Impact Or Consequence To Patient
12
12
Hemorrhage/Bleeding
9
9
No Patient Involvement
8
8
Hypersensitivity/Allergic reaction
5
5
Skin Erosion
5
5
Skin Tears
4
4
Ulcer
3
3
Chemical Exposure
2
2
No Consequences Or Impact To Patient
2
2
Dyspnea
2
2
Erythema
2
2
Exsanguination
2
2
Inflammation
2
2
Tissue Breakdown
2
2
Skin Inflammation/ Irritation
2
2
Aspiration/Inhalation
1
1
Unspecified Hepatic or Biliary Problem
1
1
Renal Impairment
1
1
Itching Sensation
1
1
Phlebitis
1
1
Hypoglycemia
1
1
Unspecified Infection
1
1
Discharge
1
1
Skin Irritation
1
1
Pressure Sores
1
1
Reaction
1
1
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