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TPLC
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Device
catheter, coude
Product Code
EZC
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
14
14
2015
20
20
2016
170
170
2017
963
963
2018
886
886
2019
1000
1000
2020
1027
1027
2021
1030
1030
2022
1365
1365
2023
1156
1156
2024
399
399
Device Problems
MDRs with this Device Problem
Events in those MDRs
Deflation Problem
1129
1129
Burst Container or Vessel
983
983
Fluid/Blood Leak
861
861
Difficult to Remove
716
716
Decrease in Pressure
497
497
Failure to Infuse
453
453
Material Puncture/Hole
443
443
Partial Blockage
372
372
Inflation Problem
339
339
Break
336
336
Leak/Splash
317
317
Inaccurate Flow Rate
296
296
Material Rupture
248
248
Device Dislodged or Dislocated
218
218
Material Fragmentation
208
208
Adverse Event Without Identified Device or Use Problem
199
199
Erratic or Intermittent Display
161
161
Device Fell
154
154
No Flow
142
142
Material Split, Cut or Torn
129
129
Component Falling
126
126
Component Missing
126
126
Device Operates Differently Than Expected
106
106
Patient Device Interaction Problem
94
94
Device Sensing Problem
81
81
Device Slipped
78
78
Obstruction of Flow
75
75
Biocompatibility
74
74
Component Misassembled
69
69
Material Deformation
67
67
Detachment of Device or Device Component
65
65
Disconnection
64
64
Incorrect Measurement
63
63
Material Invagination
59
59
Illegible Information
56
56
Patient-Device Incompatibility
55
55
Inadequate or Insufficient Training
55
55
Difficult to Insert
54
54
Device Contamination with Chemical or Other Material
53
53
Hole In Material
52
52
Complete Blockage
52
52
Detachment Of Device Component
50
50
Calcified
50
50
Material Twisted/Bent
41
41
Tear, Rip or Hole in Device Packaging
39
39
Use of Device Problem
38
38
Deformation Due to Compressive Stress
38
38
Inadequate Instructions for Healthcare Professional
38
38
Misassembled
38
38
Dent in Material
37
37
Device Handling Problem
36
36
Device Damaged Prior to Use
34
34
Short Fill
34
34
Insufficient Information
33
33
Inability to Irrigate
31
31
Gel Leak
30
30
Restricted Flow rate
30
30
Physical Resistance/Sticking
30
30
Missing Information
29
29
Nonstandard Device
28
28
Fracture
27
27
Improper or Incorrect Procedure or Method
27
27
Material Integrity Problem
27
27
Defective Component
26
26
No Display/Image
26
26
Defective Device
24
24
Inadequacy of Device Shape and/or Size
23
23
Naturally Worn
22
22
Infusion or Flow Problem
19
19
Material Protrusion/Extrusion
18
18
Crack
18
18
Filling Problem
18
18
Device Markings/Labelling Problem
17
17
Collapse
16
16
Expiration Date Error
14
14
Noise, Audible
13
13
Appropriate Term/Code Not Available
12
12
Gas/Air Leak
12
12
Physical Resistance
12
12
Insufficient Flow or Under Infusion
12
12
Product Quality Problem
11
11
Torn Material
11
11
Unclear Information
11
11
Positioning Problem
10
10
Malposition of Device
10
10
Fitting Problem
9
9
Labelling, Instructions for Use or Training Problem
9
9
Improper Flow or Infusion
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Therapeutic or Diagnostic Output Failure
8
8
Packaging Problem
8
8
Sharp Edges
8
8
Material Discolored
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Material Separation
8
8
Blocked Connection
8
8
Aspiration Issue
7
7
Failure to Advance
7
7
Sticking
7
7
Material Too Rigid or Stiff
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3461
3461
No Known Impact Or Consequence To Patient
2455
2455
No Consequences Or Impact To Patient
2002
2002
No Patient Involvement
472
472
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
363
363
Pain
270
270
Urinary Tract Infection
196
196
No Information
186
186
Foreign Body In Patient
155
155
Patient Problem/Medical Problem
148
148
No Code Available
134
134
Discomfort
116
116
Hematuria
102
102
Urinary Retention
91
91
Hemorrhage/Bleeding
58
58
Unspecified Infection
48
48
Insufficient Information
47
47
Tissue Breakdown
24
24
Hypersensitivity/Allergic reaction
23
23
Device Embedded In Tissue or Plaque
22
22
Fistula
21
21
Reaction
19
19
Incontinence
16
16
Erosion
16
16
Injury
16
16
Perforation
14
14
Blood Loss
14
14
Abdominal Distention
14
14
Cancer
14
14
Skin Inflammation/ Irritation
13
13
Irritation
12
12
Abdominal Pain
11
11
Tissue Damage
10
10
Alteration In Body Temperature
10
10
Swelling
9
9
Exposure to Body Fluids
9
9
Inflammation
9
9
Muscle Spasm(s)
8
8
Bacterial Infection
8
8
Abrasion
8
8
Burning Sensation
8
8
Unspecified Gastrointestinal Problem
8
8
Distress
7
7
Pressure Sores
7
7
Death
7
7
Erythema
7
7
Fever
7
7
Laceration(s)
6
6
Rash
6
6
Confusion/ Disorientation
6
6
Irritability
6
6
Cramp(s) /Muscle Spasm(s)
5
5
Swelling/ Edema
5
5
Skin Discoloration
5
5
Complaint, Ill-Defined
5
5
Sedation
4
4
Staphylococcus Aureus
4
4
Micturition Urgency
4
4
Sepsis
3
3
Local Reaction
3
3
Thrombus
3
3
Inadequate Pain Relief
3
3
Anxiety
3
3
Localized Skin Lesion
3
3
Unspecified Tissue Injury
3
3
Obstruction/Occlusion
2
2
Skin Tears
2
2
Not Applicable
2
2
Convulsion/Seizure
2
2
Depression
2
2
Chills
2
2
Discharge
2
2
Skin Irritation
2
2
Hematoma
2
2
High Blood Pressure/ Hypertension
2
2
Purulent Discharge
2
2
Calcium Deposits/Calcification
2
2
Chest Pain
1
1
Cyst(s)
1
1
Dementia
1
1
Edema
1
1
Emotional Changes
1
1
Abscess
1
1
Anaphylactic Shock
1
1
Aneurysm
1
1
Bruise/Contusion
1
1
Hypoglycemia
1
1
Low Blood Pressure/ Hypotension
1
1
Failure of Implant
1
1
Hemorrhage, Extradural
1
1
Nausea
1
1
Internal Organ Perforation
1
1
Itching Sensation
1
1
Respiratory Distress
1
1
Pulmonary Infarction
1
1
Uterine Perforation
1
1
Abnormal Vaginal Discharge
1
1
Thrombosis
1
1
Ulceration
1
1
Excessive Tear Production
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Sep-23-2021
2
C.R. Bard, Inc.
II
Jun-06-2018
3
C.R. Bard, Inc., Urological Division
II
Sep-07-2012
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