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TPLC
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show TPLC since
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Device
catheter, hemodialysis, non-implanted
Product Code
MPB
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
HEALTH LINE INTERNATIONAL CORPORATION
SUBSTANTIALLY EQUIVALENT - KIT
1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
119
119
2020
179
179
2021
192
192
2022
166
166
2023
204
204
2024
127
127
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Puncture/Hole
172
172
Material Deformation
92
92
Break
86
86
Difficult to Remove
75
75
Material Frayed
75
75
Product Quality Problem
68
68
Deformation Due to Compressive Stress
66
66
Fluid/Blood Leak
60
60
Unraveled Material
44
44
Crack
39
39
Physical Resistance/Sticking
38
38
Material Twisted/Bent
32
32
Obstruction of Flow
29
29
Leak/Splash
27
27
Material Separation
21
21
Migration or Expulsion of Device
20
20
Component Incompatible
20
20
Detachment of Device or Device Component
18
18
Defective Component
17
17
Migration
17
17
Adverse Event Without Identified Device or Use Problem
16
16
Material Integrity Problem
15
15
Infusion or Flow Problem
12
12
Disconnection
12
12
Contamination /Decontamination Problem
9
9
Device Markings/Labelling Problem
9
9
Insufficient Flow or Under Infusion
9
9
Failure to Infuse
9
9
Difficult to Advance
8
8
Gas/Air Leak
8
8
Difficult to Insert
7
7
Device Handling Problem
6
6
Device Damaged Prior to Use
6
6
Material Split, Cut or Torn
5
5
Insufficient Information
5
5
Air/Gas in Device
5
5
Loose or Intermittent Connection
4
4
Fitting Problem
4
4
Failure to Advance
4
4
Material Fragmentation
4
4
Suction Problem
3
3
Malposition of Device
3
3
Mechanical Problem
3
3
Suction Failure
3
3
Separation Problem
3
3
Unintended Ejection
3
3
Complete Blockage
2
2
Contamination
2
2
Unsealed Device Packaging
2
2
Device Slipped
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
580
580
No Consequences Or Impact To Patient
180
180
Insufficient Information
88
88
No Patient Involvement
29
29
No Known Impact Or Consequence To Patient
24
24
No Information
20
20
Hemorrhage/Bleeding
20
20
Foreign Body In Patient
16
16
Needle Stick/Puncture
14
14
Blood Loss
13
13
Hematoma
9
9
Unintended Radiation Exposure
8
8
No Code Available
8
8
Air Embolism
6
6
Radiation Exposure, Unintended
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Low Blood Pressure/ Hypotension
4
4
Swelling/ Edema
4
4
Death
3
3
Device Embedded In Tissue or Plaque
3
3
Failure of Implant
3
3
Cardiac Arrest
3
3
Unspecified Infection
2
2
Exsanguination
2
2
Decreased Respiratory Rate
2
2
Low Oxygen Saturation
2
2
Loss of consciousness
2
2
Headache
2
2
Skin Tears
2
2
Erythema
2
2
Pain
2
2
Bradycardia
2
2
Hemothorax
1
1
Thrombus
1
1
Bacterial Infection
1
1
Hypoxia
1
1
Anaphylactic Shock
1
1
Perforation of Vessels
1
1
Asystole
1
1
Pneumonia
1
1
Laceration(s)
1
1
Alteration in Body Temperature
1
1
Rash
1
1
Thrombosis/Thrombus
1
1
Burning Sensation
1
1
Fever
1
1
Neck Pain
1
1
Peritonitis
1
1
Overdose
1
1
Abrasion
1
1
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