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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
302
302
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
813
813
Fluid/Blood Leak
650
650
Deflation Problem
644
644
Difficult to Remove
585
585
Decrease in Pressure
494
494
Material Puncture/Hole
409
409
Failure to Infuse
378
378
Partial Blockage
274
274
Inaccurate Flow Rate
243
243
Material Fragmentation
194
194
Adverse Event Without Identified Device or Use Problem
180
180
Material Rupture
163
163
Erratic or Intermittent Display
157
157
Leak/Splash
155
155
Inflation Problem
152
152
Break
135
135
Material Split, Cut or Torn
127
127
Device Fell
124
124
Patient Device Interaction Problem
93
93
Device Dislodged or Dislocated
78
78
Device Sensing Problem
76
76
Biocompatibility
74
74
Device Slipped
70
70
Component Missing
67
67
Component Misassembled
66
66
Illegible Information
56
56
Inadequate or Insufficient Training
55
55
Obstruction of Flow
54
54
Disconnection
53
53
Material Invagination
51
51
Incorrect Measurement
47
47
Calcified
46
46
Material Deformation
44
44
No Flow
40
40
Detachment of Device or Device Component
39
39
Difficult to Insert
39
39
Device Contamination with Chemical or Other Material
38
38
Complete Blockage
37
37
Dent in Material
35
35
Material Twisted/Bent
34
34
Deformation Due to Compressive Stress
33
33
Inadequate Instructions for Healthcare Professional
33
33
Device Handling Problem
32
32
Patient-Device Incompatibility
31
31
Short Fill
31
31
Tear, Rip or Hole in Device Packaging
30
30
Missing Information
29
29
Nonstandard Device
27
27
Fracture
26
26
No Display/Image
25
25
Use of Device Problem
25
25
Misassembled
24
24
Physical Resistance/Sticking
24
24
Gel Leak
23
23
Defective Component
19
19
Inability to Irrigate
18
18
Restricted Flow rate
17
17
Insufficient Information
16
16
Material Protrusion/Extrusion
16
16
Naturally Worn
16
16
Defective Device
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
3380
3380
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
357
357
No Patient Involvement
301
301
Pain
217
217
Urinary Tract Infection
154
154
Foreign Body In Patient
130
130
Patient Problem/Medical Problem
118
118
Hematuria
83
83
Discomfort
81
81
No Code Available
66
66
Insufficient Information
47
47
Unspecified Infection
36
36
Urinary Retention
35
35
Hemorrhage/Bleeding
25
25
Tissue Breakdown
22
22
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
Swelling/ Edema
5
5
Cramp(s) /Muscle Spasm(s)
4
4
Localized Skin Lesion
3
3
Unspecified Tissue Injury
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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