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TPLC
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Device
port & catheter, implanted, subcutaneous, intravascular
Product Code
LJT
Regulation Number
880.5965
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
878
878
2019
765
765
2020
959
959
2021
1285
1285
2022
1334
1334
2023
768
768
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
1783
1783
Fluid/Blood Leak
955
955
Adverse Event Without Identified Device or Use Problem
845
845
Material Separation
610
610
Deformation Due to Compressive Stress
521
521
Break
497
497
Suction Problem
455
455
Migration
408
408
Obstruction of Flow
306
306
Naturally Worn
303
303
Difficult to Flush
297
297
Detachment of Device or Device Component
205
205
Defective Component
186
186
Component Missing
178
178
Material Protrusion/Extrusion
145
145
Appropriate Term/Code Not Available
133
133
Difficult to Remove
121
121
Disconnection
116
116
Failure to Infuse
110
110
Migration or Expulsion of Device
107
107
Material Deformation
106
106
Stretched
103
103
Failure to Advance
82
82
Air/Gas in Device
82
82
Material Puncture/Hole
81
81
Leak/Splash
66
66
Dent in Material
59
59
Device Dislodged or Dislocated
57
57
Difficult to Insert
56
56
Improper or Incorrect Procedure or Method
55
55
Crack
54
54
Material Frayed
50
50
Tear, Rip or Hole in Device Packaging
50
50
Blocked Connection
47
47
Material Twisted/Bent
46
46
Expulsion
40
40
Device Contamination with Chemical or Other Material
37
37
Component Incompatible
37
37
Difficult or Delayed Separation
36
36
Material Split, Cut or Torn
36
36
Material Rupture
32
32
Peeled/Delaminated
30
30
Device Tipped Over
28
28
Material Integrity Problem
28
28
Physical Resistance/Sticking
28
28
Insufficient Information
28
28
Infusion or Flow Problem
26
26
Aspiration Issue
26
26
Loose or Intermittent Connection
25
25
Material Discolored
22
22
Entrapment of Device
22
22
Component Misassembled
22
22
Material Fragmentation
21
21
Partial Blockage
20
20
Device Appears to Trigger Rejection
20
20
Malposition of Device
20
20
Missing Information
19
19
Fitting Problem
17
17
Connection Problem
17
17
Restricted Flow rate
17
17
Contamination
17
17
Complete Blockage
16
16
Contamination /Decontamination Problem
16
16
Device Contaminated During Manufacture or Shipping
16
16
Use of Device Problem
15
15
Expiration Date Error
15
15
Detachment Of Device Component
15
15
Flushing Problem
15
15
Nonstandard Device
14
14
Unsealed Device Packaging
14
14
Device Markings/Labelling Problem
14
14
Packaging Problem
14
14
Inaccurate Information
12
12
Defective Device
12
12
Device Damaged Prior to Use
12
12
Reflux within Device
12
12
Separation Failure
11
11
Patient-Device Incompatibility
11
11
Backflow
10
10
Difficult to Advance
9
9
Loss of or Failure to Bond
8
8
Material Too Rigid or Stiff
8
8
Separation Problem
8
8
Scratched Material
8
8
No Apparent Adverse Event
7
7
Kinked
7
7
Degraded
7
7
Material Erosion
7
7
Unraveled Material
7
7
Device Slipped
6
6
Material Perforation
6
6
Incomplete or Missing Packaging
6
6
Device-Device Incompatibility
6
6
No Display/Image
6
6
Burst Container or Vessel
6
6
Radiation Leak
6
6
Mechanical Problem
6
6
Melted
6
6
Therapeutic or Diagnostic Output Failure
6
6
Output Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2105
2105
No Consequences Or Impact To Patient
1138
1138
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
382
382
Pain
336
336
Foreign Body In Patient
264
264
No Known Impact Or Consequence To Patient
231
231
Insufficient Information
231
231
No Patient Involvement
203
203
Injury
188
188
Arrhythmia
178
178
Extravasation
156
156
Swelling/ Edema
153
153
Unspecified Infection
150
150
Device Embedded In Tissue or Plaque
98
98
Swelling
77
77
Embolism
57
57
Skin Erosion
56
56
Thrombosis/Thrombus
56
56
Discomfort
50
50
Pneumothorax
42
42
Erythema
35
35
Thrombus
35
35
Embolism/Embolus
30
30
Sepsis
30
30
Chest Pain
28
28
Bacterial Infection
27
27
Phlebitis
23
23
Infiltration into Tissue
22
22
Fever
22
22
Neck Pain
22
22
No Information
21
21
Hematoma
20
20
Hemorrhage/Bleeding
20
20
Bruise/Contusion
20
20
Failure of Implant
19
19
No Code Available
19
19
Burning Sensation
18
18
Itching Sensation
18
18
Hypersensitivity/Allergic reaction
17
17
Inflammation
17
17
Thrombosis
17
17
Edema
16
16
Rash
15
15
Local Reaction
15
15
Death
14
14
Pulmonary Embolism
13
13
Perforation of Vessels
13
13
Patient Problem/Medical Problem
12
12
Wound Dehiscence
12
12
Air Embolism
10
10
Hemothorax
10
10
Rupture
10
10
Reaction
7
7
Cellulitis
7
7
Perforation
7
7
Necrosis
6
6
Skin Discoloration
6
6
Implant Pain
6
6
Obstruction/Occlusion
5
5
Blood Loss
5
5
Chemical Exposure
4
4
Unspecified Tissue Injury
4
4
Palpitations
4
4
Post Operative Wound Infection
4
4
Numbness
4
4
Fungal Infection
4
4
Scar Tissue
4
4
Dyspnea
4
4
Cardiac Arrest
3
3
Apheresis
3
3
Erosion
3
3
Occlusion
3
3
Pleural Effusion
3
3
Pneumonia
3
3
Anxiety
3
3
Needle Stick/Puncture
3
3
Chills
3
3
Dizziness
3
3
Skin Inflammation/ Irritation
3
3
Foreign Body Embolism
3
3
Pericardial Effusion
3
3
Tissue Breakdown
3
3
Decreased Respiratory Rate
3
3
Cardiac Perforation
2
2
Caustic/Chemical Burns
2
2
Respiratory Failure
2
2
Confusion/ Disorientation
2
2
Fluid Discharge
2
2
Vascular Dissection
2
2
Skin Infection
2
2
Post Traumatic Wound Infection
2
2
Urticaria
2
2
Internal Organ Perforation
2
2
High Blood Pressure/ Hypertension
2
2
Low Blood Pressure/ Hypotension
2
2
Irritation
2
2
Seizures
2
2
Tachycardia
2
2
Exposure to Body Fluids
2
2
Anaphylactic Shock
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Apr-21-2021
2
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Nov-21-2019
3
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Oct-05-2018
4
Angiodynamics, Inc.
II
Oct-25-2022
5
Bard Peripheral Vascular Inc
II
May-10-2021
6
Bard Peripheral Vascular Inc
II
May-12-2020
7
Bard Peripheral Vascular Inc
II
Mar-26-2020
8
Bard Peripheral Vascular Inc
II
Nov-27-2019
9
Bard Peripheral Vascular Inc
II
Jul-25-2019
10
Bard Peripheral Vascular Inc
II
May-09-2018
11
Cook Vascular Inc.
II
Mar-27-2018
12
Medical Components, Inc dba MedComp
II
Mar-08-2021
13
Medical Components, Inc dba MedComp
II
Mar-29-2018
14
Medical Components, Inc dba MedComp
II
Feb-06-2018
15
Smiths Medical ASD Inc.
II
Jul-04-2020
16
Smiths Medical ASD Inc.
II
Oct-24-2019
17
Smiths Medical ASD Inc.
II
Mar-15-2018
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