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TPLC
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show TPLC since
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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
4
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
2
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
2
VYGON USA
SUBSTANTIALLY EQUIVALENT
1
WOO YOUNG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
3297
3297
2019
4364
4364
2020
3796
3796
2021
4673
4673
2022
4133
4138
2023
2967
2967
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
6848
6848
Break
2540
2540
Device Contamination with Chemical or Other Material
2427
2427
Retraction Problem
1639
1639
Fluid/Blood Leak
1100
1100
Material Separation
800
800
Deformation Due to Compressive Stress
738
738
Material Deformation
707
707
Adverse Event Without Identified Device or Use Problem
555
555
Defective Component
551
551
Material Protrusion/Extrusion
485
485
Material Puncture/Hole
473
473
Crack
437
437
Detachment of Device or Device Component
430
430
Material Split, Cut or Torn
354
359
Physical Resistance/Sticking
343
343
Unraveled Material
306
306
Packaging Problem
299
299
Material Twisted/Bent
245
245
Difficult or Delayed Activation
244
244
Difficult to Remove
227
227
Defective Device
223
223
Difficult to Advance
199
199
Material Frayed
197
197
Difficult to Insert
186
186
Dull, Blunt
185
185
Device Markings/Labelling Problem
182
182
Obstruction of Flow
175
175
Component Missing
175
175
Contamination
166
166
Fracture
163
163
Activation Problem
163
163
Complete Blockage
145
145
Contamination /Decontamination Problem
133
133
Loose or Intermittent Connection
130
130
Failure to Advance
117
117
Product Quality Problem
117
117
Unsealed Device Packaging
115
115
Device Damaged Prior to Use
113
113
Material Fragmentation
110
110
Material Integrity Problem
106
106
Delivered as Unsterile Product
102
102
Fail-Safe Problem
98
98
Material Rupture
96
96
Improper or Incorrect Procedure or Method
89
89
Material Perforation
82
82
Entrapment of Device
79
79
Infusion or Flow Problem
78
78
Device Operates Differently Than Expected
78
78
Insufficient Information
75
75
Fitting Problem
71
71
Mechanical Problem
69
69
Protective Measures Problem
69
69
Nonstandard Device
67
67
Disconnection
66
66
Detachment Of Device Component
60
60
Kinked
60
60
Microbial Contamination of Device
59
59
Structural Problem
55
55
Fail-Safe Did Not Operate
53
53
Patient-Device Incompatibility
51
51
Gas/Air Leak
50
50
Separation Problem
45
45
Appropriate Term/Code Not Available
45
45
Difficult or Delayed Positioning
44
44
Tear, Rip or Hole in Device Packaging
43
43
Failure to Deliver
43
43
Sticking
43
43
Improper Flow or Infusion
43
43
Device Dislodged or Dislocated
41
41
Difficult To Position
41
41
Use of Device Problem
41
41
Material Discolored
38
38
Free or Unrestricted Flow
38
38
Activation, Positioning or Separation Problem
34
34
Connection Problem
34
34
Manufacturing, Packaging or Shipping Problem
29
29
Backflow
29
29
Difficult to Flush
29
29
Separation Failure
29
29
Stretched
28
28
Degraded
28
28
Bent
27
27
Positioning Problem
27
27
Difficult or Delayed Separation
27
27
Air/Gas in Device
27
27
Missing Information
26
26
Output Problem
26
26
Physical Resistance
25
25
Material Too Rigid or Stiff
25
25
Problem with Sterilization
24
24
Failure to Infuse
24
24
Illegible Information
23
23
Device Fell
22
22
Biocompatibility
22
22
Flushing Problem
22
22
Burst Container or Vessel
21
21
Therapeutic or Diagnostic Output Failure
21
21
Patient Device Interaction Problem
21
21
Mechanical Jam
20
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
9352
9357
No Known Impact Or Consequence To Patient
5862
5862
No Consequences Or Impact To Patient
3271
3271
Foreign Body In Patient
741
741
Insufficient Information
709
709
No Patient Involvement
595
595
Pain
405
405
No Information
376
376
Needle Stick/Puncture
363
363
No Code Available
231
231
Device Embedded In Tissue or Plaque
228
228
Bacterial Infection
172
172
Exposure to Body Fluids
167
167
Blood Loss
149
149
Hemorrhage/Bleeding
148
148
Extravasation
136
136
Phlebitis
111
111
Unspecified Infection
105
105
Hypersensitivity/Allergic reaction
100
100
Infiltration into Tissue
70
70
Erythema
65
65
Swelling
64
64
Hematoma
63
63
Discomfort
54
54
Bruise/Contusion
53
53
Thrombosis/Thrombus
53
53
Swelling/ Edema
49
49
Inflammation
49
49
Death
39
39
Injury
39
39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
39
39
Fever
38
38
Perforation of Vessels
35
40
Skin Inflammation/ Irritation
33
33
Anaphylactic Shock
28
28
Low Blood Pressure/ Hypotension
26
26
Thrombus
26
26
Skin Inflammation
22
22
Abscess
21
21
Reaction
20
20
Sepsis
20
20
Failure of Implant
19
19
Thrombosis
18
18
Rupture
15
15
Itching Sensation
15
15
Tissue Damage
14
14
Laceration(s)
13
13
Chemical Exposure
13
13
Patient Problem/Medical Problem
13
13
Cardiac Arrest
12
12
Air Embolism
11
11
Skin Discoloration
11
11
Rash
10
10
Chills
9
9
Cellulitis
9
9
Edema
9
9
Necrosis
9
9
Numbness
8
8
Distress
8
8
Local Reaction
8
8
Skin Tears
8
8
Skin Irritation
7
7
Reaction, Injection Site
7
7
Complaint, Ill-Defined
7
7
Burning Sensation
7
7
Nausea
7
8
Abrasion
7
7
High Blood Pressure/ Hypertension
6
6
Hemostasis
6
6
Venipuncture
6
6
Tachycardia
6
6
Radiation Exposure, Unintended
6
6
Fluid Discharge
5
5
Vomiting
5
5
Weakness
5
5
Respiratory Distress
5
5
Pneumonia
5
5
Perforation
5
5
Loss of consciousness
5
5
Obstruction/Occlusion
5
5
Hemolysis
5
5
Fatigue
5
5
Feeding Problem
5
5
Dyspnea
4
5
Vessel Or Plaque, Device Embedded In
4
4
Bradycardia
4
4
Emotional Changes
4
4
Anxiety
4
4
Alteration In Body Temperature
4
4
Underdose
4
4
Embolism/Embolus
4
4
Unintended Radiation Exposure
4
4
Reaction to Medicinal Component of Device
3
3
Foreign Body Embolism
3
3
Bronchospasm
3
3
Tissue Breakdown
3
3
Not Applicable
3
3
Ulcer
3
3
Chest Tightness/Pressure
3
3
Pneumothorax
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Jun-21-2023
2
ARROW INTERNATIONAL Inc.
I
Dec-10-2022
3
ARROW INTERNATIONAL Inc.
II
Jun-27-2022
4
Access Vascular, Inc
II
Feb-22-2023
5
Access Vascular, Inc
II
Feb-22-2023
6
Access Vascular, Inc
II
Feb-10-2023
7
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Jun-14-2018
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
Arrow International Inc
II
Nov-14-2018
14
Arrow International Inc
II
Oct-26-2018
15
Arrow International Inc
II
Aug-22-2018
16
Arrow International Inc
II
Aug-14-2018
17
Arrow International Inc
II
May-30-2018
18
Arrow International Inc
II
Apr-10-2018
19
Arrow International Inc
II
Mar-21-2018
20
Arrow International Inc
II
Mar-14-2018
21
Arrow International Inc
II
Mar-14-2018
22
Arrow International Inc
II
Mar-05-2018
23
Arrow International Inc
II
Feb-20-2018
24
B Braun Medical Inc
II
Oct-06-2022
25
Becton Dickinson & Company
II
Oct-19-2020
26
Becton Dickinson & Company
II
Jun-03-2019
27
Becton Dickinson & Company
II
Nov-04-2018
28
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-03-2022
29
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-24-2021
30
Braxton Medical Corporation
II
Jan-27-2021
31
Cook Inc.
II
Mar-24-2020
32
Cook Inc.
II
Feb-15-2018
33
Delta Med SpA
II
Aug-16-2021
34
Janus Trade Group
II
Nov-30-2020
35
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
36
Smiths Medical ASD Inc.
II
Nov-08-2019
37
Smiths Medical ASD Inc.
II
Apr-25-2019
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