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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
AMECO MEDICAL INDUSTRIES
SUBSTANTIALLY EQUIVALENT
1
C.R BARD INC.
SUBSTANTIALLY EQUIVALENT
1
C.R BARD. INC.
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
COOK, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT - KIT
1
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
GAMBRO RENAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
HEALTH LINE INTERNATIONAL CORPORATION
SUBSTANTIALLY EQUIVALENT - KIT
1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
82
82
2015
51
51
2016
70
70
2017
86
86
2018
120
120
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
175
175
Break
130
130
Difficult to Remove
102
102
Material Deformation
101
101
Fluid/Blood Leak
94
94
Material Frayed
90
90
Crack
82
82
Unraveled Material
76
76
Product Quality Problem
73
73
Deformation Due to Compressive Stress
66
66
Leak/Splash
65
65
Kinked
58
58
Physical Resistance/Sticking
44
44
Material Twisted/Bent
37
37
Obstruction of Flow
30
30
Physical Resistance
29
29
Material Separation
28
28
Migration or Expulsion of Device
26
26
Material Integrity Problem
23
23
Adverse Event Without Identified Device or Use Problem
23
23
Detachment of Device or Device Component
20
20
Component Incompatible
20
20
Infusion or Flow Problem
19
19
Defective Component
18
18
Migration
17
17
Device Operates Differently Than Expected
17
17
Disconnection
14
14
Difficult to Insert
12
12
Loose or Intermittent Connection
11
11
Sticking
10
10
Device Damaged Prior to Use
10
10
Difficult to Advance
10
10
Bent
9
9
Insufficient Flow or Under Infusion
9
9
Appropriate Term/Code Not Available
9
9
Device Markings/Labelling Problem
9
9
Failure to Advance
9
9
Gas/Air Leak
9
9
Failure to Infuse
9
9
Hole In Material
9
9
Contamination /Decontamination Problem
9
9
Device Handling Problem
8
8
Fracture
8
8
Device Slipped
7
7
Material Split, Cut or Torn
7
7
Improper or Incorrect Procedure or Method
6
6
Insufficient Information
6
6
Retraction Problem
6
6
Delivered as Unsterile Product
6
6
Air/Gas in Device
5
5
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
311
311
No Known Impact Or Consequence To Patient
177
177
Insufficient Information
88
88
No Information
61
61
Blood Loss
41
41
No Patient Involvement
39
39
Needle Stick/Puncture
28
28
No Code Available
25
25
Hemorrhage/Bleeding
23
23
Foreign Body In Patient
17
17
Air Embolism
10
10
Hematoma
9
9
Unintended Radiation Exposure
8
8
Radiation Exposure, Unintended
6
6
Death
6
6
Device Embedded In Tissue or Plaque
5
5
Low Blood Pressure/ Hypotension
4
4
Swelling/ Edema
4
4
Pain
4
4
Cardiac Arrest
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Failure of Implant
3
3
Low Oxygen Saturation
3
3
Perforation
3
3
Exsanguination
3
3
Headache
3
3
Laceration(s)
3
3
Unspecified Infection
3
3
Injury
3
3
Decreased Respiratory Rate
2
2
Hemothorax
2
2
Loss of consciousness
2
2
Skin Tears
2
2
Bradycardia
2
2
Cardiopulmonary Arrest
2
2
Erythema
2
2
Peritonitis
2
2
Anemia
2
2
Reaction, Injection Site
2
2
Neck Pain
1
1
Fever
1
1
Burning Sensation
1
1
Thrombosis/Thrombus
1
1
Rash
1
1
Hypovolemic Shock
1
1
Discomfort
1
1
Vomiting
1
1
Cardiogenic Shock
1
1
Overdose
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Apr-10-2018
2
Arrow International Inc
II
Feb-20-2018
3
Arrow International Inc
II
Jun-12-2017
4
Cordis Corporation
II
Aug-18-2015
5
Medical Components, Inc dba MedComp
II
Aug-25-2018
6
Medtronic Minimally Invasive Therapies Group
II
Mar-14-2018
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