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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
2014
18
18
2015
41
41
2016
19
19
2017
45
45
2018
40
40
2019
10
10
2020
14
14
2021
33
33
2022
103
103
2023
140
140
2024
91
91
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
176
176
Loss of or Failure to Bond
78
78
Adverse Event Without Identified Device or Use Problem
35
35
Misconnection
31
31
Defective Component
24
24
Break
13
13
Difficult to Remove
12
12
Device Disinfection Or Sterilization Issue
11
11
Device Dislodged or Dislocated
11
11
Device Operates Differently Than Expected
11
11
Failure To Adhere Or Bond
11
11
Delivered as Unsterile Product
10
10
Detachment Of Device Component
9
9
Patient-Device Incompatibility
8
8
Difficult or Delayed Positioning
8
8
Improper or Incorrect Procedure or Method
8
8
Material Separation
7
7
Leak/Splash
7
7
Disconnection
7
7
Patient Device Interaction Problem
7
7
Mechanical Problem
7
7
Fluid/Blood Leak
6
6
Use of Device Problem
6
6
Contamination
6
6
Unsealed Device Packaging
6
6
Difficult to Open or Close
5
5
Material Twisted/Bent
5
5
Component Misassembled
4
4
Device Damaged Prior to Use
4
4
Nonstandard Device
3
3
Appropriate Term/Code Not Available
3
3
Misassembled
3
3
Mechanics Altered
3
3
Contamination /Decontamination Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Positioning Problem
3
3
Device Slipped
3
3
Physical Property Issue
2
2
Peeled/Delaminated
2
2
Device Contamination with Chemical or Other Material
2
2
Crack
2
2
Sticking
2
2
Malposition of Device
2
2
Migration or Expulsion of Device
2
2
Material Integrity Problem
2
2
Separation Problem
2
2
Connection Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Difficult or Delayed Separation
2
2
Flaked
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
327
327
No Known Impact Or Consequence To Patient
119
119
No Patient Involvement
14
14
Insufficient Information
13
13
No Consequences Or Impact To Patient
11
11
Hemorrhage/Bleeding
10
10
Hypersensitivity/Allergic reaction
9
9
Skin Tears
9
9
No Code Available
7
7
Skin Erosion
7
7
Erythema
5
5
Pressure Sores
4
4
Reaction
4
4
Rash
4
4
Ulcer
3
3
No Information
3
3
Inflammation
3
3
Tissue Breakdown
2
2
Dyspnea
2
2
Irritation
2
2
Injury
2
2
Confusion/ Disorientation
2
2
Chemical Exposure
2
2
Itching Sensation
2
2
Exsanguination
2
2
Skin Inflammation/ Irritation
2
2
Skin Irritation
2
2
Sepsis
2
2
Unspecified Infection
2
2
Abrasion
1
1
Foreign Body In Patient
1
1
Needle Stick/Puncture
1
1
Local Reaction
1
1
Edema
1
1
Swelling
1
1
Skin Inflammation
1
1
Aspiration/Inhalation
1
1
Unspecified Hepatic or Biliary Problem
1
1
Renal Impairment
1
1
Pain
1
1
Venipuncture
1
1
Hypoglycemia
1
1
Anxiety
1
1
Contact Dermatitis
1
1
Tissue Damage
1
1
Discharge
1
1
Phlebitis
1
1
Death
1
1
Patient Problem/Medical Problem
1
1
Urticaria
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Access Systems
II
Jan-10-2017
2
Bard Access Systems
II
Jun-28-2013
3
Bard Access Systems Inc.
II
May-19-2017
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