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TPLC
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show TPLC since
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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
677
677
Device Problems
MDRs with this Device Problem
Events in those MDRs
Deflation Problem
1140
1140
Burst Container or Vessel
983
983
Fluid/Blood Leak
881
881
Difficult to Remove
743
743
Material Puncture/Hole
502
502
Decrease in Pressure
497
497
Failure to Infuse
457
457
Partial Blockage
377
377
Inflation Problem
354
354
Break
336
336
Leak/Splash
317
317
Material Rupture
317
317
Inaccurate Flow Rate
308
308
Material Fragmentation
219
219
Device Dislodged or Dislocated
219
219
Adverse Event Without Identified Device or Use Problem
199
199
Erratic or Intermittent Display
163
163
Device Fell
154
154
No Flow
142
142
Material Split, Cut or Torn
132
132
Component Missing
131
131
Component Falling
126
126
Device Operates Differently Than Expected
106
106
Patient Device Interaction Problem
97
97
Device Sensing Problem
92
92
Device Slipped
78
78
Obstruction of Flow
75
75
Biocompatibility
75
75
Component Misassembled
71
71
Material Deformation
67
67
Disconnection
66
66
Incorrect Measurement
66
66
Detachment of Device or Device Component
65
65
Material Invagination
59
59
Illegible Information
56
56
Patient-Device Incompatibility
55
55
Inadequate or Insufficient Training
55
55
Device Contamination with Chemical or Other Material
55
55
Difficult to Insert
54
54
Complete Blockage
53
53
Hole In Material
52
52
Detachment Of Device Component
50
50
Calcified
50
50
Tear, Rip or Hole in Device Packaging
43
43
Material Twisted/Bent
42
42
Deformation Due to Compressive Stress
40
40
Dent in Material
40
40
Device Handling Problem
39
39
Use of Device Problem
38
38
Inadequate Instructions for Healthcare Professional
38
38
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3699
3699
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
380
380
Pain
275
275
Urinary Tract Infection
199
199
No Information
186
186
Foreign Body In Patient
165
165
Patient Problem/Medical Problem
148
148
No Code Available
134
134
Discomfort
119
119
Hematuria
103
103
Urinary Retention
93
93
Hemorrhage/Bleeding
59
59
Unspecified Infection
49
49
Insufficient Information
48
48
Hypersensitivity/Allergic reaction
27
27
Tissue Breakdown
24
24
Device Embedded In Tissue or Plaque
22
22
Fistula
21
21
Reaction
19
19
Incontinence
18
18
Injury
16
16
Erosion
16
16
Cancer
14
14
Blood Loss
14
14
Abdominal Distention
14
14
Perforation
14
14
Skin Inflammation/ Irritation
13
13
Abdominal Pain
13
13
Irritation
12
12
Tissue Damage
10
10
Alteration In Body Temperature
10
10
Exposure to Body Fluids
10
10
Inflammation
9
9
Swelling
9
9
Bacterial Infection
8
8
Abrasion
8
8
Unspecified Gastrointestinal Problem
8
8
Burning Sensation
8
8
Muscle Spasm(s)
8
8
Pressure Sores
7
7
Fever
7
7
Death
7
7
Distress
7
7
Erythema
7
7
Swelling/ Edema
6
6
Laceration(s)
6
6
Irritability
6
6
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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