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TPLC
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Device
catheter, hemodialysis, implanted
Product Code
MSD
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
BARD PERIPHERAL VASCULAR, INC
SUBSTANTIALLY EQUIVALENT - KIT
1
C B BARD, INC
SUBSTANTIALLY EQUIVALENT - KIT
1
C R BARD, INC
SUBSTANTIALLY EQUIVALENT - KIT
1
C.R. BARD
SUBSTANTIALLY EQUIVALENT - KIT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT - KIT
2
MARVAO MEDICAL DEVICES, LTD.
SUBSTANTIALLY EQUIVALENT - KIT
1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
SUBSTANTIALLY EQUIVALENT
1
MEDICAL COMPONENTS INC. (MEDCOMP)
SUBSTANTIALLY EQUIVALENT
1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
SUBSTANTIALLY EQUIVALENT - KIT
1
PRISTINE ACCESS TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
462
462
2019
645
645
2020
401
401
2021
523
523
2022
610
610
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Component
328
328
Break
299
299
Fluid/Blood Leak
244
244
Fracture
209
209
Material Puncture/Hole
204
204
Material Deformation
182
182
Crack
142
142
Detachment of Device or Device Component
123
123
Leak/Splash
117
117
Deformation Due to Compressive Stress
81
81
Material Integrity Problem
79
79
Material Opacification
72
72
Stretched
63
63
Device Dislodged or Dislocated
63
63
Obstruction of Flow
62
62
Difficult to Remove
56
56
Material Separation
53
53
Component Missing
48
48
Material Protrusion/Extrusion
45
45
Adverse Event Without Identified Device or Use Problem
45
45
Insufficient Flow or Under Infusion
42
42
Kinked
41
41
Material Frayed
40
40
Material Discolored
38
38
Air/Gas in Device
38
38
Appropriate Term/Code Not Available
37
37
Restricted Flow rate
35
35
Disconnection
34
34
Loosening of Implant Not Related to Bone-Ingrowth
34
34
Infusion or Flow Problem
33
33
Expulsion
33
33
Migration or Expulsion of Device
33
33
Product Quality Problem
32
32
Suction Problem
30
30
Failure To Adhere Or Bond
26
26
Failure to Advance
21
21
Collapse
19
19
Tear, Rip or Hole in Device Packaging
18
18
Material Twisted/Bent
18
18
Packaging Problem
17
17
Material Split, Cut or Torn
17
17
Insufficient Information
16
16
Migration
16
16
Loss of or Failure to Bond
16
16
Material Fragmentation
16
16
Connection Problem
15
15
Contamination /Decontamination Problem
13
13
Occlusion Within Device
12
12
Unsealed Device Packaging
12
12
Difficult to Insert
11
11
Component Incompatible
11
11
Physical Resistance/Sticking
11
11
Difficult or Delayed Separation
10
10
Device Markings/Labelling Problem
10
10
Failure to Infuse
10
10
Material Rupture
10
10
Hole In Material
9
9
Gas/Air Leak
9
9
Device Contamination with Chemical or Other Material
8
8
Unraveled Material
8
8
Melted
8
8
Misconnection
7
7
Nonstandard Device
7
7
Reflux within Device
7
7
Improper or Incorrect Procedure or Method
7
7
Ambient Temperature Problem
7
7
Separation Failure
7
7
Improper Flow or Infusion
6
6
No Fail-Safe Mechanism
6
6
Component Misassembled
6
6
Use of Device Problem
6
6
Sticking
6
6
Device Damaged Prior to Use
6
6
Loose or Intermittent Connection
6
6
Difficult to Flush
6
6
Detachment Of Device Component
6
6
Difficult to Advance
5
5
Device Operates Differently Than Expected
5
5
Human-Device Interface Problem
4
4
Contamination
4
4
Bent
4
4
Burst Container or Vessel
3
3
Complete Blockage
3
3
Corroded
3
3
Dent in Material
3
3
Fitting Problem
3
3
Peeled/Delaminated
3
3
No Flow
3
3
Operating System Becomes Nonfunctional
3
3
Defective Device
3
3
Protective Measures Problem
3
3
Premature Separation
3
3
Inaccurate Information
2
2
Suction Failure
2
2
Wireless Communication Problem
2
2
Malposition of Device
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Difficult to Open or Remove Packaging Material
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Appears to Trigger Rejection
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1030
1030
No Consequences Or Impact To Patient
868
868
No Known Impact Or Consequence To Patient
219
219
No Patient Involvement
173
173
Insufficient Information
73
73
Blood Loss
50
50
Hemorrhage/Bleeding
46
46
No Information
38
38
Unspecified Infection
37
37
Death
26
26
Foreign Body In Patient
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
24
24
Injury
22
22
Thrombosis/Thrombus
18
18
Device Embedded In Tissue or Plaque
17
17
Air Embolism
14
14
Exsanguination
12
12
Skin Erosion
12
12
No Code Available
12
12
Bacterial Infection
11
11
Unintended Radiation Exposure
11
11
Fever
9
9
Cardiac Arrest
9
9
Hematoma
8
8
Embolism/Embolus
5
5
Pain
5
5
Drug Resistant Bacterial Infection
4
4
Cardiac Tamponade
4
4
Sepsis
4
4
Perforation of Vessels
4
4
Shock
4
4
Swelling/ Edema
4
4
Unspecified Tissue Injury
3
3
Tissue Damage
3
3
Renal Failure
3
3
Loss of consciousness
3
3
Perforation
3
3
Failure of Implant
3
3
Radiation Exposure, Unintended
3
3
Respiratory Distress
3
3
Distress
3
3
Stenosis
2
2
Impaired Healing
2
2
Cardiac Perforation
2
2
Chest Pain
2
2
Tissue Breakdown
2
2
Thrombus
2
2
Fluid Discharge
2
2
Swelling
2
2
Chills
2
2
Septic Shock
2
2
Low Blood Pressure/ Hypotension
2
2
Dyspnea
2
2
Patient Problem/Medical Problem
2
2
Not Applicable
1
1
Hypoxia
1
1
Heart Block
1
1
Respiratory Insufficiency
1
1
Great Vessel Perforation
1
1
Diminished Pulse Pressure
1
1
Bruise/Contusion
1
1
Stroke/CVA
1
1
Hemoptysis
1
1
Endocarditis
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Hypovolemia
1
1
Pulmonary Embolism
1
1
Low Oxygen Saturation
1
1
Osteomyelitis
1
1
Infiltration into Tissue
1
1
High Blood Pressure/ Hypertension
1
1
Anemia
1
1
Cardiopulmonary Arrest
1
1
Encephalopathy
1
1
Extravasation
1
1
Hemorrhagic Stroke
1
1
Embolism
1
1
Embolus
1
1
Hemothorax
1
1
Pneumonia
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Post Operative Wound Infection
1
1
Atrial Fibrillation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Peripheral Vascular Inc
II
Jun-03-2020
2
Bard Peripheral Vascular Inc
II
Aug-26-2019
3
Covidien Llc
I
Jul-07-2022
4
Covidien, LP
II
Aug-27-2021
5
MARVAO MEDICAL DEVICES LTD.
II
Jun-01-2021
6
Medical Components, Inc dba MedComp
II
Sep-06-2020
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