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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
203
203
2024
145
145
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Puncture/Hole
173
173
Material Deformation
95
95
Break
86
86
Material Frayed
76
76
Difficult to Remove
75
75
Product Quality Problem
69
69
Deformation Due to Compressive Stress
66
66
Fluid/Blood Leak
63
63
Unraveled Material
45
45
Physical Resistance/Sticking
40
40
Crack
39
39
Material Twisted/Bent
35
35
Obstruction of Flow
30
30
Leak/Splash
27
27
Migration or Expulsion of Device
21
21
Material Separation
21
21
Component Incompatible
20
20
Detachment of Device or Device Component
19
19
Adverse Event Without Identified Device or Use Problem
17
17
Defective Component
17
17
Migration
17
17
Material Integrity Problem
15
15
Disconnection
13
13
Infusion or Flow Problem
12
12
Insufficient Flow or Under Infusion
10
10
Contamination /Decontamination Problem
9
9
Failure to Infuse
9
9
Device Markings/Labelling Problem
9
9
Difficult to Advance
8
8
Gas/Air Leak
8
8
Difficult to Insert
7
7
Device Damaged Prior to Use
6
6
Device Handling Problem
6
6
Insufficient Information
5
5
Air/Gas in Device
5
5
Material Fragmentation
5
5
Material Split, Cut or Torn
5
5
Failure to Advance
4
4
Separation Problem
4
4
Loose or Intermittent Connection
4
4
Fitting Problem
4
4
Suction Failure
3
3
Suction Problem
3
3
Unintended Ejection
3
3
Malposition of Device
3
3
Mechanical Problem
3
3
Device Contamination with Chemical or Other Material
2
2
Device Dislodged or Dislocated
2
2
Tear, Rip or Hole in Device Packaging
2
2
Connection Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
592
592
No Consequences Or Impact To Patient
180
180
Insufficient Information
93
93
No Patient Involvement
29
29
No Known Impact Or Consequence To Patient
24
24
Hemorrhage/Bleeding
21
21
No Information
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
Device Embedded In Tissue or Plaque
3
3
Cardiac Arrest
3
3
Failure of Implant
3
3
Death
3
3
Thrombosis/Thrombus
2
2
Erythema
2
2
Exsanguination
2
2
Pain
2
2
Bradycardia
2
2
Skin Tears
2
2
Headache
2
2
Loss of consciousness
2
2
Low Oxygen Saturation
2
2
Decreased Respiratory Rate
2
2
Unspecified Infection
2
2
Abrasion
1
1
Overdose
1
1
Peritonitis
1
1
Embolism/Embolus
1
1
Perforation
1
1
Fever
1
1
Burning Sensation
1
1
Neck Pain
1
1
Ischemia
1
1
Discomfort
1
1
Alteration in Body Temperature
1
1
Laceration(s)
1
1
Pneumonia
1
1
Asystole
1
1
Dizziness
1
1
Perforation of Vessels
1
1
Hypoxia
1
1
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