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TPLC
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Device
catheter, intravascular, therapeutic, short-term less than 30 days
Product Code
FOZ
Regulation Number
880.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCESS VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
ACCESS VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
3
B.BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
3
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
SUBSTANTIALLY EQUIVALENT
2
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
5
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
2
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC
SUBSTANTIALLY EQUIVALENT
1
COOK ADVANCED TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
DELTA MED SPA
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MEDIKIT LIMITED
SUBSTANTIALLY EQUIVALENT
1
HEALTH LINE INTERNATIONAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MEDIFIRST CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDIPLUS (INDIA) LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDSOURCE INTERNATIONAL LLC
SUBSTANTIALLY EQUIVALENT
1
MEDSOURCE LABS
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SINGAPORE PTE. LTD.
SUBSTANTIALLY EQUIVALENT
1
POLY MEDICURE LIMITED
SUBSTANTIALLY EQUIVALENT
3
SAUDI MAIS CO. FOR MEDICAL PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SKYDANCE VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
2
TOGO MEDIKIT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VYGON USA
SUBSTANTIALLY EQUIVALENT
1
WOO YOUNG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
4364
4364
2020
3796
3796
2021
4673
4673
2022
4133
4138
2023
4430
4433
2024
617
617
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
6818
6818
Break
2374
2374
Device Contamination with Chemical or Other Material
2282
2282
Retraction Problem
1588
1588
Fluid/Blood Leak
1019
1019
Deformation Due to Compressive Stress
805
805
Material Separation
785
785
Material Deformation
690
690
Defective Component
687
687
Adverse Event Without Identified Device or Use Problem
535
535
Material Puncture/Hole
524
527
Material Protrusion/Extrusion
485
485
Crack
408
408
Material Split, Cut or Torn
374
379
Detachment of Device or Device Component
366
366
Physical Resistance/Sticking
342
342
Unraveled Material
303
303
Packaging Problem
281
281
Difficult or Delayed Activation
266
266
Material Twisted/Bent
258
258
Material Frayed
234
234
Defective Device
222
222
Difficult to Remove
198
198
Activation Problem
186
186
Contamination
174
174
Device Markings/Labelling Problem
171
171
Obstruction of Flow
167
167
Fracture
163
163
Complete Blockage
147
147
Difficult to Insert
147
147
Component Missing
137
137
Loose or Intermittent Connection
118
118
Improper or Incorrect Procedure or Method
98
98
Contamination /Decontamination Problem
94
94
Difficult to Advance
94
94
Product Quality Problem
92
92
Material Fragmentation
90
90
Material Rupture
90
90
Device Damaged Prior to Use
89
89
Delivered as Unsterile Product
87
87
Fail-Safe Problem
86
86
Failure to Advance
83
83
Fitting Problem
75
75
Material Perforation
72
75
Insufficient Information
70
70
Infusion or Flow Problem
68
68
Dull, Blunt
61
61
Entrapment of Device
57
57
Material Integrity Problem
56
56
Protective Measures Problem
54
54
Unsealed Device Packaging
53
53
Mechanical Problem
51
51
Separation Problem
48
48
Fail-Safe Did Not Operate
45
45
Failure to Deliver
44
44
Improper Flow or Infusion
42
42
Free or Unrestricted Flow
38
38
Patient-Device Incompatibility
38
38
Disconnection
37
37
Device Dislodged or Dislocated
34
34
Air/Gas in Device
34
34
Tear, Rip or Hole in Device Packaging
33
33
Stretched
32
32
Backflow
32
32
Missing Information
30
30
Use of Device Problem
29
29
Gas/Air Leak
28
28
Material Discolored
28
28
Separation Failure
27
27
Difficult or Delayed Separation
27
27
Failure to Infuse
26
26
Difficult to Flush
25
25
Connection Problem
24
24
Activation, Positioning or Separation Problem
24
24
Output Problem
24
24
Patient Device Interaction Problem
23
23
Illegible Information
23
23
Biocompatibility
23
23
Therapeutic or Diagnostic Output Failure
21
21
Activation Failure
20
20
Wrong Label
20
20
Material Too Soft/Flexible
19
19
Mechanical Jam
19
19
Insufficient Flow or Under Infusion
19
19
Flushing Problem
19
19
Migration or Expulsion of Device
18
18
Material Too Rigid or Stiff
18
18
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Positioning Problem
18
18
Migration
18
18
Appropriate Term/Code Not Available
18
18
Fungus in Device Environment
17
17
Partial Blockage
14
14
Failure to Disconnect
13
13
Device Fell
13
13
Labelling, Instructions for Use or Training Problem
12
12
Burst Container or Vessel
11
11
Contamination of Device Ingredient or Reagent
11
11
Structural Problem
11
11
Suction Failure
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
10971
10979
No Known Impact Or Consequence To Patient
4051
4051
No Consequences Or Impact To Patient
2536
2536
Insufficient Information
954
954
Foreign Body In Patient
753
753
No Patient Involvement
534
534
Pain
355
355
Needle Stick/Puncture
343
343
No Information
250
250
Device Embedded In Tissue or Plaque
160
160
Exposure to Body Fluids
158
158
No Code Available
152
152
Hemorrhage/Bleeding
149
149
Extravasation
136
136
Blood Loss
124
124
Phlebitis
110
110
Bacterial Infection
103
103
Hypersensitivity/Allergic reaction
95
95
Erythema
63
63
Hematoma
61
61
Unspecified Infection
61
61
Infiltration into Tissue
60
60
Thrombosis/Thrombus
57
57
Swelling/ Edema
55
55
Skin Inflammation/ Irritation
55
55
Bruise/Contusion
50
50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
47
47
Inflammation
46
46
Swelling
45
45
Discomfort
43
43
Perforation of Vessels
36
41
Anaphylactic Shock
30
30
Injury
28
28
Low Blood Pressure/ Hypotension
26
26
Thrombus
24
24
Failure of Implant
23
23
Abscess
20
20
Skin Inflammation
20
20
Death
19
19
Fever
19
19
Reaction
18
18
Rupture
16
16
Sepsis
15
15
Thrombosis
13
13
Laceration(s)
13
13
Chemical Exposure
13
13
Itching Sensation
12
12
Cardiac Arrest
11
11
Tissue Damage
10
10
Rash
10
10
Air Embolism
9
9
Abrasion
8
8
Necrosis
8
8
Skin Discoloration
8
8
Tachycardia
7
7
Burning Sensation
7
7
Skin Tears
7
7
Patient Problem/Medical Problem
7
7
Foreign Body Embolism
7
7
Numbness
6
6
Venipuncture
6
6
Anxiety
6
6
Skin Irritation
6
6
High Blood Pressure/ Hypertension
6
6
Hemostasis
6
6
Cellulitis
6
6
Edema
6
6
Hemolysis
5
5
Feeding Problem
5
5
Chills
5
5
Local Reaction
5
5
Obstruction/Occlusion
5
5
Reaction, Injection Site
5
5
Fluid Discharge
5
5
Radiation Exposure, Unintended
4
4
Embolism/Embolus
4
4
Unintended Radiation Exposure
4
4
Underdose
4
4
Scar Tissue
4
4
Pneumothorax
4
4
Perforation
4
4
Vomiting
4
4
Emotional Changes
4
4
Bradycardia
4
4
Bronchitis
3
3
Arrhythmia
3
3
Vessel Or Plaque, Device Embedded In
3
3
Dyspnea
3
3
Infarction, Cerebral
3
3
Hypoglycemia
3
3
Fatigue
3
3
Weakness
3
3
Nausea
3
3
Chest Tightness/Pressure
3
3
Distress
3
3
Ulcer
3
3
Complaint, Ill-Defined
3
3
Reaction to Medicinal Component of Device
3
3
Unspecified Tissue Injury
3
3
Respiratory Arrest
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Oct-05-2023
2
ARROW INTERNATIONAL Inc.
I
Jun-21-2023
3
ARROW INTERNATIONAL Inc.
I
Dec-10-2022
4
ARROW INTERNATIONAL Inc.
II
Jun-27-2022
5
Access Vascular, Inc
II
Feb-22-2023
6
Access Vascular, Inc
II
Feb-22-2023
7
Access Vascular, Inc
II
Feb-10-2023
8
Angiodynamics, Inc.
II
Jun-17-2020
9
Arrow International Inc
II
Feb-10-2021
10
Arrow International Inc
II
Jan-22-2020
11
Arrow International Inc
II
Oct-24-2019
12
Arrow International Inc
II
Oct-07-2019
13
B Braun Medical Inc
II
Oct-06-2022
14
Becton Dickinson & Company
II
Oct-19-2020
15
Becton Dickinson & Company
II
Jun-03-2019
16
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-24-2023
17
Becton Dickinson Infusion Therapy Systems Inc.
II
Oct-03-2023
18
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-03-2022
19
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-24-2021
20
Braxton Medical Corporation
II
Jan-27-2021
21
Cook Inc.
II
Mar-24-2020
22
Delta Med SpA
II
Aug-16-2021
23
Janus Trade Group
II
Nov-30-2020
24
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
25
Smiths Medical ASD Inc.
II
Nov-08-2019
26
Smiths Medical ASD Inc.
II
Apr-25-2019
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