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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
1288
1288
2022
1335
1335
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
1488
1488
Fluid/Blood Leak
833
833
Adverse Event Without Identified Device or Use Problem
681
681
Break
486
486
Material Separation
464
464
Deformation Due to Compressive Stress
443
443
Suction Problem
373
373
Migration
333
333
Naturally Worn
276
276
Obstruction of Flow
271
271
Difficult to Flush
231
231
Detachment of Device or Device Component
189
189
Defective Component
180
180
Component Missing
175
175
Appropriate Term/Code Not Available
133
133
Material Protrusion/Extrusion
126
126
Failure to Infuse
109
109
Migration or Expulsion of Device
106
106
Material Deformation
104
104
Disconnection
103
103
Difficult to Remove
100
100
Stretched
85
85
Failure to Advance
69
69
Air/Gas in Device
63
63
Material Puncture/Hole
61
61
Leak/Splash
61
61
Device Dislodged or Dislocated
51
51
Material Frayed
50
50
Crack
46
46
Tear, Rip or Hole in Device Packaging
45
45
Improper or Incorrect Procedure or Method
45
45
Dent in Material
42
42
Material Twisted/Bent
42
42
Difficult to Insert
42
42
Component Incompatible
37
37
Device Contamination with Chemical or Other Material
35
35
Difficult or Delayed Separation
35
35
Blocked Connection
32
32
Material Rupture
31
31
Peeled/Delaminated
30
30
Expulsion
30
30
Material Split, Cut or Torn
27
27
Aspiration Issue
26
26
Insufficient Information
25
25
Loose or Intermittent Connection
21
21
Partial Blockage
20
20
Infusion or Flow Problem
20
20
Component Misassembled
20
20
Device Tipped Over
19
19
Material Fragmentation
18
18
Missing Information
18
18
Contamination
17
17
Material Discolored
16
16
Entrapment of Device
16
16
Detachment Of Device Component
15
15
Restricted Flow rate
15
15
Malposition of Device
15
15
Expiration Date Error
15
15
Physical Resistance/Sticking
15
15
Fitting Problem
14
14
Device Contaminated During Manufacture or Shipping
14
14
Device Markings/Labelling Problem
14
14
Contamination /Decontamination Problem
14
14
Connection Problem
14
14
Packaging Problem
14
14
Unsealed Device Packaging
14
14
Complete Blockage
14
14
Nonstandard Device
13
13
Device Damaged Prior to Use
13
13
Use of Device Problem
13
13
Flushing Problem
12
12
Inaccurate Information
12
12
Patient-Device Incompatibility
11
11
Material Integrity Problem
11
11
Reflux within Device
10
10
Device Appears to Trigger Rejection
10
10
Backflow
9
9
Difficult to Advance
9
9
Separation Failure
9
9
Defective Device
9
9
Scratched Material
8
8
Material Too Rigid or Stiff
8
8
Kinked
7
7
Degraded
7
7
Material Erosion
7
7
Burst Container or Vessel
6
6
Mechanical Problem
6
6
Melted
6
6
Device Slipped
6
6
Therapeutic or Diagnostic Output Failure
6
6
Output Problem
6
6
Device-Device Incompatibility
6
6
Incomplete or Missing Packaging
6
6
Material Perforation
6
6
No Apparent Adverse Event
6
6
Separation Problem
5
5
Illegible Information
5
5
Difficult to Open or Close
5
5
Misassembled
5
5
No Display/Image
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1628
1628
No Consequences Or Impact To Patient
1138
1138
Pain
307
307
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
305
305
No Known Impact Or Consequence To Patient
231
231
Foreign Body In Patient
228
228
No Patient Involvement
203
203
Insufficient Information
191
191
Injury
188
188
Arrhythmia
152
152
Extravasation
141
141
Swelling/ Edema
129
129
Unspecified Infection
111
111
Device Embedded In Tissue or Plaque
92
92
Swelling
77
77
Embolism
57
57
Discomfort
49
49
Skin Erosion
48
48
Thrombosis/Thrombus
44
44
Pneumothorax
38
38
Thrombus
35
35
Erythema
31
31
Sepsis
27
27
Embolism/Embolus
27
27
Phlebitis
22
22
Infiltration into Tissue
21
21
Chest Pain
21
21
No Information
21
21
Neck Pain
20
20
Fever
20
20
No Code Available
19
19
Bruise/Contusion
18
18
Bacterial Infection
17
17
Thrombosis
17
17
Burning Sensation
17
17
Hemorrhage/Bleeding
16
16
Edema
16
16
Inflammation
16
16
Hypersensitivity/Allergic reaction
16
16
Itching Sensation
16
16
Hematoma
14
14
Local Reaction
14
14
Death
14
14
Pulmonary Embolism
13
13
Rash
12
12
Failure of Implant
12
12
Patient Problem/Medical Problem
12
12
Wound Dehiscence
11
11
Rupture
10
10
Air Embolism
9
9
Hemothorax
9
9
Perforation of Vessels
8
8
Reaction
7
7
Cellulitis
6
6
Necrosis
6
6
Perforation
6
6
Skin Discoloration
5
5
Obstruction/Occlusion
5
5
Blood Loss
5
5
Numbness
4
4
Post Operative Wound Infection
4
4
Palpitations
4
4
Dyspnea
4
4
Cardiac Arrest
3
3
Apheresis
3
3
Erosion
3
3
Scar Tissue
3
3
Pleural Effusion
3
3
Occlusion
3
3
Decreased Respiratory Rate
3
3
Chills
3
3
Dizziness
3
3
Unspecified Tissue Injury
3
3
Implant Pain
3
3
Pericardial Effusion
3
3
Tissue Breakdown
3
3
Fluid Discharge
2
2
Confusion/ Disorientation
2
2
Chemical Exposure
2
2
Respiratory Failure
2
2
Caustic/Chemical Burns
2
2
Vascular Dissection
2
2
Foreign Body Embolism
2
2
Skin Infection
2
2
Skin Inflammation/ Irritation
2
2
Urticaria
2
2
Anxiety
2
2
Cardiac Perforation
2
2
Post Traumatic Wound Infection
2
2
Needle Stick/Puncture
2
2
Fungal Infection
2
2
Pneumonia
2
2
High Blood Pressure/ Hypertension
2
2
Irritation
2
2
Seizures
2
2
Exposure to Body Fluids
2
2
Anaphylactic Shock
2
2
Anemia
2
2
Foreign Body Reaction
2
2
Headache
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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