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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
1
MDR Year
MDR Reports
MDR Events
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
Burst Container or Vessel
817
817
Deflation Problem
653
653
Fluid/Blood Leak
653
653
Difficult to Remove
596
596
Decrease in Pressure
497
497
Material Puncture/Hole
430
430
Failure to Infuse
379
379
Partial Blockage
277
277
Inaccurate Flow Rate
244
244
Material Fragmentation
202
202
Adverse Event Without Identified Device or Use Problem
180
180
Material Rupture
176
176
Erratic or Intermittent Display
157
157
Inflation Problem
155
155
Leak/Splash
155
155
Break
135
135
Material Split, Cut or Torn
129
129
Device Fell
124
124
Patient Device Interaction Problem
94
94
Device Sensing Problem
80
80
Device Dislodged or Dislocated
78
78
Biocompatibility
74
74
Device Slipped
70
70
Component Misassembled
69
69
Component Missing
68
68
Illegible Information
56
56
Inadequate or Insufficient Training
55
55
Disconnection
54
54
Obstruction of Flow
54
54
Material Invagination
52
52
Calcified
47
47
Incorrect Measurement
47
47
Material Deformation
44
44
No Flow
40
40
Detachment of Device or Device Component
39
39
Difficult to Insert
39
39
Complete Blockage
38
38
Device Contamination with Chemical or Other Material
38
38
Dent in Material
36
36
Device Handling Problem
35
35
Material Twisted/Bent
34
34
Deformation Due to Compressive Stress
34
34
Inadequate Instructions for Healthcare Professional
33
33
Short Fill
31
31
Tear, Rip or Hole in Device Packaging
31
31
Patient-Device Incompatibility
31
31
Missing Information
29
29
Nonstandard Device
27
27
Fracture
26
26
No Display/Image
26
26
Use of Device Problem
25
25
Misassembled
24
24
Physical Resistance/Sticking
24
24
Gel Leak
23
23
Inability to Irrigate
21
21
Defective Component
19
19
Restricted Flow rate
17
17
Defective Device
17
17
Insufficient Information
16
16
Material Protrusion/Extrusion
16
16
Naturally Worn
16
16
Expiration Date Error
14
14
Device Damaged Prior to Use
14
14
Material Integrity Problem
14
14
Collapse
14
14
Inadequacy of Device Shape and/or Size
14
14
Gas/Air Leak
11
11
Unclear Information
11
11
Device Markings/Labelling Problem
10
10
Improper or Incorrect Procedure or Method
10
10
Fitting Problem
9
9
Filling Problem
8
8
Therapeutic or Diagnostic Output Failure
8
8
Sharp Edges
8
8
Inaccurate Information
7
7
No Apparent Adverse Event
7
7
Infusion or Flow Problem
7
7
Material Separation
7
7
Product Quality Problem
6
6
Crack
6
6
Noise, Audible
6
6
Positioning Problem
6
6
Output Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Failure to Advance
5
5
Malposition of Device
5
5
Entrapment of Device
5
5
Unsealed Device Packaging
5
5
Shipping Damage or Problem
5
5
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Degraded
4
4
Flaked
4
4
Material Discolored
4
4
Labelling, Instructions for Use or Training Problem
4
4
Contamination /Decontamination Problem
4
4
Fungus in Device Environment
4
4
Improper Chemical Reaction
4
4
Improper Flow or Infusion
4
4
Packaging Problem
4
4
Scratched Material
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3461
3461
No Consequences Or Impact To Patient
1431
1431
No Known Impact Or Consequence To Patient
1174
1174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
363
363
No Patient Involvement
301
301
Pain
220
220
Urinary Tract Infection
154
154
Foreign Body In Patient
134
134
Patient Problem/Medical Problem
118
118
Hematuria
84
84
Discomfort
82
82
No Code Available
66
66
Insufficient Information
47
47
Unspecified Infection
37
37
Urinary Retention
35
35
Hemorrhage/Bleeding
25
25
Tissue Breakdown
23
23
Fistula
21
21
No Information
20
20
Hypersensitivity/Allergic reaction
19
19
Erosion
15
15
Perforation
14
14
Cancer
14
14
Device Embedded In Tissue or Plaque
13
13
Skin Inflammation/ Irritation
13
13
Incontinence
12
12
Abdominal Distention
11
11
Exposure to Body Fluids
9
9
Abdominal Pain
8
8
Abrasion
8
8
Inflammation
8
8
Irritation
8
8
Unspecified Gastrointestinal Problem
8
8
Reaction
7
7
Distress
7
7
Tissue Damage
6
6
Irritability
6
6
Swelling
6
6
Skin Discoloration
5
5
Laceration(s)
5
5
Bacterial Infection
5
5
Erythema
5
5
Fever
5
5
Blood Loss
5
5
Pressure Sores
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Swelling/ Edema
5
5
Unspecified Tissue Injury
3
3
Localized Skin Lesion
3
3
Anxiety
3
3
Burning Sensation
3
3
Injury
3
3
Micturition Urgency
3
3
Muscle Spasm(s)
3
3
Rash
3
3
Local Reaction
2
2
Sepsis
2
2
Thrombus
2
2
High Blood Pressure/ Hypertension
2
2
Calcium Deposits/Calcification
2
2
Depression
2
2
Inadequate Pain Relief
2
2
Obstruction/Occlusion
2
2
Skin Tears
2
2
Alteration In Body Temperature
2
2
Chills
2
2
Convulsion/Seizure
2
2
Not Applicable
2
2
Urethral Stenosis/Stricture
1
1
Genital Bleeding
1
1
Cramp(s)
1
1
Tingling
1
1
Ulceration
1
1
Uterine Perforation
1
1
Abnormal Vaginal Discharge
1
1
Discharge
1
1
Excessive Tear Production
1
1
Subclinical Infection
1
1
Sneezing
1
1
Urinary Frequency
1
1
Dysuria
1
1
Inadequate Osseointegration
1
1
Bowel Perforation
1
1
Confusion/ Disorientation
1
1
Spinal Cord Injury
1
1
Cyst(s)
1
1
Death
1
1
Edema
1
1
Low Blood Pressure/ Hypotension
1
1
Hematoma
1
1
Skin Irritation
1
1
Nausea
1
1
Internal Organ Perforation
1
1
Itching Sensation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Sep-23-2021
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