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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
2023
350
350
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Component
334
334
Break
332
332
Fluid/Blood Leak
299
299
Fracture
285
285
Material Puncture/Hole
245
245
Material Deformation
190
190
Crack
166
166
Leak/Splash
133
133
Detachment of Device or Device Component
130
130
Deformation Due to Compressive Stress
112
112
Material Integrity Problem
85
85
Obstruction of Flow
82
82
Material Opacification
77
77
Material Separation
71
71
Stretched
71
71
Difficult to Remove
63
63
Device Dislodged or Dislocated
63
63
Adverse Event Without Identified Device or Use Problem
56
56
Material Protrusion/Extrusion
50
50
Component Missing
49
49
Insufficient Flow or Under Infusion
49
49
Air/Gas in Device
48
48
Material Discolored
44
44
Loosening of Implant Not Related to Bone-Ingrowth
43
43
Expulsion
43
43
Kinked
41
41
Restricted Flow rate
40
40
Material Frayed
40
40
Product Quality Problem
40
40
Appropriate Term/Code Not Available
38
38
Disconnection
37
37
Migration or Expulsion of Device
35
35
Infusion or Flow Problem
35
35
Suction Problem
34
34
Failure to Advance
29
29
Failure To Adhere Or Bond
26
26
Material Twisted/Bent
25
25
Migration
25
25
Material Fragmentation
21
21
Collapse
20
20
Insufficient Information
20
20
Material Split, Cut or Torn
20
20
Gas/Air Leak
19
19
Tear, Rip or Hole in Device Packaging
18
18
Packaging Problem
17
17
Loss of or Failure to Bond
17
17
Difficult to Insert
17
17
Physical Resistance/Sticking
16
16
Connection Problem
16
16
Contamination /Decontamination Problem
14
14
Device Markings/Labelling Problem
14
14
Difficult or Delayed Separation
13
13
Unsealed Device Packaging
13
13
Occlusion Within Device
12
12
Component Incompatible
11
11
Separation Failure
11
11
Failure to Infuse
10
10
Unraveled Material
10
10
Material Rupture
10
10
Hole In Material
9
9
Difficult to Flush
8
8
Melted
8
8
Device Contamination with Chemical or Other Material
8
8
Ambient Temperature Problem
7
7
Reflux within Device
7
7
Misconnection
7
7
Nonstandard Device
7
7
Improper or Incorrect Procedure or Method
7
7
Device Damaged Prior to Use
7
7
Use of Device Problem
6
6
Sticking
6
6
Loose or Intermittent Connection
6
6
Detachment Of Device Component
6
6
Difficult to Advance
6
6
No Fail-Safe Mechanism
6
6
Component Misassembled
6
6
Improper Flow or Infusion
6
6
Device Operates Differently Than Expected
5
5
Defective Device
4
4
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
Entrapment of Device
3
3
Fitting Problem
3
3
Peeled/Delaminated
3
3
No Flow
3
3
Dent in Material
3
3
Operating System Becomes Nonfunctional
3
3
Protective Measures Problem
3
3
Premature Separation
3
3
Inaccurate Information
2
2
Suction Failure
2
2
Separation Problem
2
2
Wireless Communication Problem
2
2
Patient-Device Incompatibility
2
2
Malposition of Device
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1317
1317
No Consequences Or Impact To Patient
868
868
No Known Impact Or Consequence To Patient
219
219
No Patient Involvement
173
173
Insufficient Information
98
98
Hemorrhage/Bleeding
58
58
Blood Loss
50
50
Unspecified Infection
42
42
No Information
38
38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
31
31
Death
26
26
Foreign Body In Patient
26
26
Thrombosis/Thrombus
23
23
Injury
22
22
Air Embolism
18
18
Device Embedded In Tissue or Plaque
17
17
Unintended Radiation Exposure
15
15
No Code Available
12
12
Skin Erosion
12
12
Bacterial Infection
12
12
Cardiac Arrest
12
12
Exsanguination
12
12
Fever
9
9
Hematoma
9
9
Pain
7
7
Loss of consciousness
6
6
Embolism/Embolus
6
6
Swelling/ Edema
5
5
Perforation of Vessels
5
5
Sepsis
5
5
Shock
5
5
Low Blood Pressure/ Hypotension
5
5
Cardiac Tamponade
4
4
Drug Resistant Bacterial Infection
4
4
Unspecified Tissue Injury
3
3
Tissue Damage
3
3
Distress
3
3
Failure of Implant
3
3
Radiation Exposure, Unintended
3
3
Perforation
3
3
Renal Failure
3
3
Respiratory Distress
3
3
Dyspnea
3
3
Chest Pain
2
2
High Blood Pressure/ Hypertension
2
2
Patient Problem/Medical Problem
2
2
Tissue Breakdown
2
2
Fluid Discharge
2
2
Impaired Healing
2
2
Cardiac Perforation
2
2
Confusion/ Disorientation
2
2
Septic Shock
2
2
Swelling
2
2
Thrombus
2
2
Peritonitis
2
2
Stenosis
2
2
Chills
2
2
Respiratory Arrest
2
2
Respiratory Insufficiency
2
2
Osteomyelitis
1
1
Hemorrhagic Stroke
1
1
Heart Block
1
1
Pericarditis
1
1
Aspiration Pneumonitis
1
1
Dizziness
1
1
Hypovolemia
1
1
Vomiting
1
1
Great Vessel Perforation
1
1
Lethargy
1
1
Diminished Pulse Pressure
1
1
Post Operative Wound Infection
1
1
Low Oxygen Saturation
1
1
Fibrosis
1
1
Not Applicable
1
1
Pulmonary Embolism
1
1
Hemothorax
1
1
Hypersensitivity/Allergic reaction
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Nausea
1
1
Internal Organ Perforation
1
1
Pneumonia
1
1
Hypoxia
1
1
Paralysis
1
1
Cyanosis
1
1
Cardiopulmonary Arrest
1
1
Stroke/CVA
1
1
Bradycardia
1
1
Bruise/Contusion
1
1
Anemia
1
1
Atrial Fibrillation
1
1
Embolism
1
1
Embolus
1
1
Encephalopathy
1
1
Endocarditis
1
1
Hemoptysis
1
1
Extravasation
1
1
Fatigue
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 LP
II
Sep-25-2023
4
Covidien Llc
I
Jul-07-2022
5
Covidien, LP
II
Aug-27-2021
6
MARVAO MEDICAL DEVICES LTD.
II
Jun-01-2021
7
Medical Components, Inc dba MedComp
II
Sep-06-2020
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