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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
1154
1154
2024
129
129
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
785
785
Deflation Problem
637
637
Fluid/Blood Leak
631
631
Difficult to Remove
555
555
Decrease in Pressure
476
476
Material Puncture/Hole
381
381
Failure to Infuse
370
370
Partial Blockage
270
270
Inaccurate Flow Rate
235
235
Material Fragmentation
189
189
Adverse Event Without Identified Device or Use Problem
180
180
Material Rupture
160
160
Leak/Splash
155
155
Inflation Problem
152
152
Erratic or Intermittent Display
152
152
Break
135
135
Material Split, Cut or Torn
124
124
Device Fell
124
124
Patient Device Interaction Problem
92
92
Device Dislodged or Dislocated
77
77
Device Sensing Problem
74
74
Biocompatibility
74
74
Device Slipped
70
70
Component Missing
67
67
Component Misassembled
64
64
Illegible Information
56
56
Inadequate or Insufficient Training
55
55
Obstruction of Flow
54
54
Disconnection
51
51
Material Invagination
50
50
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
38
38
Complete Blockage
37
37
Device Contamination with Chemical or Other Material
37
37
Dent in Material
35
35
Deformation Due to Compressive Stress
33
33
Inadequate Instructions for Healthcare Professional
33
33
Material Twisted/Bent
32
32
Patient-Device Incompatibility
31
31
Short Fill
31
31
Tear, Rip or Hole in Device Packaging
29
29
Missing Information
29
29
Device Handling Problem
29
29
Nonstandard Device
27
27
Fracture
26
26
Use of Device Problem
25
25
Misassembled
24
24
No Display/Image
24
24
Physical Resistance/Sticking
24
24
Gel Leak
23
23
Defective Component
19
19
Inability to Irrigate
17
17
Restricted Flow rate
17
17
Material Protrusion/Extrusion
16
16
Naturally Worn
16
16
Defective Device
16
16
Insufficient Information
15
15
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
Sharp Edges
8
8
Therapeutic or Diagnostic Output Failure
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
3222
3222
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
347
347
No Patient Involvement
301
301
Pain
213
213
Urinary Tract Infection
153
153
Foreign Body In Patient
130
130
Patient Problem/Medical Problem
118
118
Hematuria
83
83
Discomfort
78
78
No Code Available
66
66
Insufficient Information
46
46
Unspecified Infection
35
35
Urinary Retention
34
34
Hemorrhage/Bleeding
24
24
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
12
12
Incontinence
12
12
Abdominal Distention
11
11
Exposure to Body Fluids
9
9
Abrasion
8
8
Inflammation
8
8
Irritation
8
8
Unspecified Gastrointestinal Problem
8
8
Abdominal Pain
7
7
Distress
7
7
Reaction
7
7
Irritability
6
6
Tissue Damage
6
6
Swelling
6
6
Laceration(s)
5
5
Bacterial Infection
5
5
Erythema
5
5
Fever
5
5
Pressure Sores
5
5
Blood Loss
5
5
Skin Discoloration
4
4
Cramp(s) /Muscle Spasm(s)
4
4
Swelling/ Edema
4
4
Localized Skin Lesion
3
3
Rash
3
3
Muscle Spasm(s)
3
3
Micturition Urgency
3
3
Injury
3
3
Anxiety
3
3
Burning Sensation
3
3
Chills
2
2
Depression
2
2
Inadequate Pain Relief
2
2
Skin Tears
2
2
High Blood Pressure/ Hypertension
2
2
Calcium Deposits/Calcification
2
2
Local Reaction
2
2
Sepsis
2
2
Thrombus
2
2
Unspecified Tissue Injury
2
2
Not Applicable
2
2
Convulsion/Seizure
2
2
Alteration In Body Temperature
2
2
Dysuria
1
1
Urethral Stenosis/Stricture
1
1
Genital Bleeding
1
1
Skin Irritation
1
1
Nausea
1
1
Internal Organ Perforation
1
1
Itching Sensation
1
1
Cyst(s)
1
1
Death
1
1
Edema
1
1
Low Blood Pressure/ Hypotension
1
1
Hematoma
1
1
Confusion/ Disorientation
1
1
Inadequate Osseointegration
1
1
Bowel Perforation
1
1
Obstruction/Occlusion
1
1
Spinal Cord Injury
1
1
Cramp(s)
1
1
Discharge
1
1
Excessive Tear Production
1
1
Subclinical Infection
1
1
Sneezing
1
1
Urinary Frequency
1
1
Tingling
1
1
Uterine Perforation
1
1
Abnormal Vaginal Discharge
1
1
Ulceration
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Sep-23-2021
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