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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
3
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
2
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC
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 LABS
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SINGAPORE PTE. LTD.
SUBSTANTIALLY EQUIVALENT
1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
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
3295
3295
2019
4364
4364
2020
3796
3796
2021
4673
4673
2022
4136
4141
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
6302
6302
Device Contamination with Chemical or Other Material
2370
2370
Break
2264
2264
Retraction Problem
1212
1212
Fluid/Blood Leak
960
960
Material Separation
649
649
Material Deformation
630
630
Deformation Due to Compressive Stress
576
576
Adverse Event Without Identified Device or Use Problem
499
499
Material Protrusion/Extrusion
473
473
Detachment of Device or Device Component
389
389
Crack
377
377
Material Puncture/Hole
355
355
Defective Component
327
327
Physical Resistance/Sticking
285
285
Material Split, Cut or Torn
283
288
Packaging Problem
274
274
Unraveled Material
263
263
Difficult or Delayed Activation
213
213
Difficult to Remove
200
200
Material Twisted/Bent
196
196
Difficult to Advance
189
189
Defective Device
180
180
Dull, Blunt
179
179
Difficult to Insert
167
167
Device Markings/Labelling Problem
166
166
Material Frayed
165
165
Component Missing
149
149
Fracture
143
143
Obstruction of Flow
141
141
Complete Blockage
136
136
Contamination /Decontamination Problem
130
130
Activation Problem
120
120
Unsealed Device Packaging
110
110
Failure to Advance
110
110
Device Damaged Prior to Use
107
107
Loose or Intermittent Connection
107
107
Material Integrity Problem
103
103
Delivered as Unsterile Product
100
100
Material Fragmentation
99
99
Product Quality Problem
96
96
Contamination
93
93
Material Rupture
85
85
Improper or Incorrect Procedure or Method
78
78
Device Operates Differently Than Expected
78
78
Infusion or Flow Problem
77
77
Fail-Safe Problem
76
76
Entrapment of Device
72
72
Material Perforation
69
69
Insufficient Information
68
68
Nonstandard Device
67
67
Protective Measures Problem
66
66
Disconnection
62
62
Kinked
60
60
Detachment Of Device Component
60
60
Microbial Contamination of Device
59
59
Fitting Problem
58
58
Structural Problem
55
55
Mechanical Problem
53
53
Patient-Device Incompatibility
51
51
Fail-Safe Did Not Operate
49
49
Gas/Air Leak
45
45
Sticking
43
43
Appropriate Term/Code Not Available
43
43
Difficult To Position
41
41
Failure to Deliver
41
41
Difficult or Delayed Positioning
41
41
Tear, Rip or Hole in Device Packaging
40
40
Use of Device Problem
39
39
Free or Unrestricted Flow
37
37
Improper Flow or Infusion
36
36
Material Discolored
36
36
Device Dislodged or Dislocated
35
35
Separation Problem
35
35
Activation, Positioning or Separation Problem
33
33
Connection Problem
31
31
Manufacturing, Packaging or Shipping Problem
28
28
Degraded
27
27
Bent
27
27
Positioning Problem
26
26
Output Problem
25
25
Physical Resistance
25
25
Problem with Sterilization
24
24
Illegible Information
23
23
Missing Information
23
23
Difficult to Flush
23
23
Flushing Problem
22
22
Stretched
22
22
Backflow
22
22
Device Fell
22
22
Material Too Rigid or Stiff
22
22
Burst Container or Vessel
20
20
Air/Gas in Device
20
20
Failure to Infuse
20
20
Difficult or Delayed Separation
20
20
Therapeutic or Diagnostic Output Failure
20
20
Mechanical Jam
19
19
Occlusion Within Device
18
18
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Separation Failure
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7058
7063
No Known Impact Or Consequence To Patient
5862
5862
No Consequences Or Impact To Patient
3271
3271
No Patient Involvement
595
595
Foreign Body In Patient
591
591
Insufficient Information
502
502
No Information
376
376
Pain
328
328
Needle Stick/Puncture
307
307
No Code Available
231
231
Device Embedded In Tissue or Plaque
221
221
Bacterial Infection
167
167
Blood Loss
149
149
Exposure to Body Fluids
144
144
Extravasation
120
120
Hemorrhage/Bleeding
112
112
Unspecified Infection
101
101
Hypersensitivity/Allergic reaction
99
99
Phlebitis
89
89
Swelling
64
64
Infiltration into Tissue
64
64
Erythema
59
59
Hematoma
58
58
Bruise/Contusion
46
46
Thrombosis/Thrombus
43
43
Inflammation
39
39
Death
39
39
Injury
39
39
Discomfort
37
37
Fever
33
33
Swelling/ Edema
32
32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
32
32
Thrombus
26
26
Skin Inflammation
22
22
Anaphylactic Shock
22
22
Low Blood Pressure/ Hypotension
20
20
Perforation of Vessels
20
20
Sepsis
20
20
Reaction
20
20
Abscess
18
18
Thrombosis
18
18
Skin Inflammation/ Irritation
17
17
Tissue Damage
14
14
Itching Sensation
14
14
Patient Problem/Medical Problem
13
13
Chemical Exposure
13
13
Rupture
12
12
Skin Discoloration
11
11
Air Embolism
11
11
Rash
10
10
Laceration(s)
10
10
Cardiac Arrest
10
10
Cellulitis
9
9
Edema
9
9
Chills
9
9
Local Reaction
8
8
Necrosis
8
8
Distress
8
8
Numbness
8
8
Reaction, Injection Site
7
7
Skin Irritation
7
7
Complaint, Ill-Defined
7
7
Nausea
7
8
Abrasion
7
7
Venipuncture
6
6
Tachycardia
6
6
Hemostasis
6
6
Radiation Exposure, Unintended
6
6
High Blood Pressure/ Hypertension
6
6
Failure of Implant
5
5
Fatigue
5
5
Perforation
5
5
Respiratory Distress
5
5
Pneumonia
5
5
Weakness
5
5
Burning Sensation
5
5
Feeding Problem
5
5
Skin Tears
5
5
Loss of consciousness
5
5
Unintended Radiation Exposure
4
4
Fluid Discharge
4
4
Vomiting
4
4
Anxiety
4
4
Alteration In Body Temperature
4
4
Underdose
4
4
Vessel Or Plaque, Device Embedded In
4
4
Emotional Changes
4
4
Hepatitis
3
3
Ulcer
3
3
Staphylococcus Aureus
3
3
Tissue Breakdown
3
3
Bronchospasm
3
3
Chest Tightness/Pressure
3
3
Pneumothorax
3
3
Diarrhea
3
3
Dyspnea
3
4
Not Applicable
3
3
Hypoxia
3
3
Hyperemia
3
3
Bronchitis
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Dec-10-2022
2
ARROW INTERNATIONAL Inc.
II
Jun-27-2022
3
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Jun-14-2018
4
Angiodynamics, Inc.
II
Jun-17-2020
5
Arrow International Inc
II
Feb-10-2021
6
Arrow International Inc
II
Jan-22-2020
7
Arrow International Inc
II
Oct-24-2019
8
Arrow International Inc
II
Oct-07-2019
9
Arrow International Inc
II
Nov-14-2018
10
Arrow International Inc
II
Oct-26-2018
11
Arrow International Inc
II
Aug-22-2018
12
Arrow International Inc
II
Aug-14-2018
13
Arrow International Inc
II
May-30-2018
14
Arrow International Inc
II
Apr-10-2018
15
Arrow International Inc
II
Mar-21-2018
16
Arrow International Inc
II
Mar-14-2018
17
Arrow International Inc
II
Mar-14-2018
18
Arrow International Inc
II
Mar-05-2018
19
Arrow International Inc
II
Feb-20-2018
20
B Braun Medical Inc
II
Oct-06-2022
21
Becton Dickinson & Company
II
Oct-19-2020
22
Becton Dickinson & Company
II
Jun-03-2019
23
Becton Dickinson & Company
II
Nov-04-2018
24
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-03-2022
25
Becton Dickinson Infusion Therapy Systems Inc.
II
Nov-24-2021
26
Braxton Medical Corporation
II
Jan-27-2021
27
Cook Inc.
II
Mar-24-2020
28
Cook Inc.
II
Feb-15-2018
29
Delta Med SpA
II
Aug-16-2021
30
Janus Trade Group
II
Nov-30-2020
31
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
32
Smiths Medical ASD Inc.
II
Nov-08-2019
33
Smiths Medical ASD Inc.
II
Apr-25-2019
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