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TPLC
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show TPLC since
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Device
catheter, straight
Product Code
EZD
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADAPTA MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
2
AMSINO INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
1
AMSINO INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ASTRA TECH AB
SUBSTANTIALLY EQUIVALENT
1
ASTRA TECH, INC.
SUBSTANTIALLY EQUIVALENT
1
BIG BLUE BIOTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
BONREE MEDICAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
SUBSTANTIALLY EQUIVALENT
4
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST
SUBSTANTIALLY EQUIVALENT
5
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST MANUFACTURING US, LLC
SUBSTANTIALLY EQUIVALENT
1
COMPACTCATH INC
SUBSTANTIALLY EQUIVALENT
1
COMPACTCATH INC.
SUBSTANTIALLY EQUIVALENT
1
COMPACTCATH, INC.
SUBSTANTIALLY EQUIVALENT
1
CONVATEC
SUBSTANTIALLY EQUIVALENT
1
CONVATEC, INC.
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT
1
CURE MEDICAL LLC.
SUBSTANTIALLY EQUIVALENT
2
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
2
DYNAREX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
FOOTPRINT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HOLLISTER INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
2
ROCHESTER MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO. LTD
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
WELLSPECT HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
ZHANJIANG STAR ENTERPRISE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
17
17
2015
21
21
2016
21
21
2017
120
120
2018
390
390
2019
466
466
2020
563
563
2021
994
994
2022
486
486
2023
555
555
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
672
672
Defective Device
577
577
Product Quality Problem
484
484
Improper Chemical Reaction
340
340
Difficult to Insert
286
286
Sharp Edges
172
172
Patient-Device Incompatibility
159
159
Difficult to Remove
156
156
Biocompatibility
151
151
Material Integrity Problem
147
147
Incorrect Measurement
140
140
Material Twisted/Bent
113
113
Component Misassembled
102
102
Component Missing
91
91
Inaccurate Flow Rate
66
66
Device Damaged Prior to Use
65
65
Inadequacy of Device Shape and/or Size
64
64
Misassembled
53
53
Nonstandard Device
52
52
Insufficient Information
52
52
Material Fragmentation
51
51
Difficult to Open or Close
43
43
Unsealed Device Packaging
35
35
Material Deformation
32
32
Manufacturing, Packaging or Shipping Problem
31
31
Contamination /Decontamination Problem
31
31
Appropriate Term/Code Not Available
31
31
Scratched Material
31
31
Device Operates Differently Than Expected
30
30
Therapeutic or Diagnostic Output Failure
28
28
Device Handling Problem
28
28
No Flow
27
27
Delivered as Unsterile Product
26
26
Fluid/Blood Leak
24
24
Material Protrusion/Extrusion
23
23
Defective Component
18
18
Partial Blockage
17
17
Patient Device Interaction Problem
17
17
Leak/Splash
16
16
Use of Device Problem
16
16
Break
15
15
Bent
12
12
Tear, Rip or Hole in Device Packaging
12
12
Structural Problem
12
12
Material Too Rigid or Stiff
12
12
Physical Resistance/Sticking
12
12
Obstruction of Flow
12
12
Inadequate Instructions for Healthcare Professional
11
11
Short Fill
10
10
Material Too Soft/Flexible
10
10
Moisture or Humidity Problem
9
9
Material Split, Cut or Torn
8
8
Improper or Incorrect Procedure or Method
8
8
Deformation Due to Compressive Stress
7
7
Device Markings/Labelling Problem
7
7
Device Misassembled During Manufacturing /Shipping
7
7
Device Contamination with Chemical or Other Material
7
7
Difficult to Open or Remove Packaging Material
6
6
Infusion or Flow Problem
6
6
Off-Label Use
6
6
Kinked
6
6
Material Puncture/Hole
5
5
Device Inoperable
5
5
Incomplete or Missing Packaging
5
5
Detachment of Device or Device Component
5
5
Device Ingredient or Reagent Problem
4
4
Packaging Problem
4
4
Inadequate Lubrication
4
4
Illegible Information
4
4
Out-Of-Box Failure
4
4
Material Separation
4
4
Shipping Damage or Problem
4
4
Labelling, Instructions for Use or Training Problem
4
4
Fracture
4
4
Mechanical Problem
3
3
Device Emits Odor
3
3
Burst Container or Vessel
3
3
Contamination
3
3
Disconnection
3
3
Restricted Flow rate
3
3
Insufficient Flow or Under Infusion
3
3
Failure to Advance
3
3
Missing Information
3
3
Positioning Problem
3
3
Output Problem
3
3
No Apparent Adverse Event
3
3
Improper Flow or Infusion
3
3
Difficult to Advance
2
2
Blocked Connection
2
2
Cut In Material
2
2
Protective Measures Problem
2
2
Dull, Blunt
2
2
Microbial Contamination of Device
2
2
Device Slipped
2
2
Sticking
2
2
Detachment Of Device Component
2
2
Flaked
2
2
Crack
2
2
Deflation Problem
2
2
Positioning Failure
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1320
1320
Urinary Tract Infection
832
832
No Consequences Or Impact To Patient
673
673
No Known Impact Or Consequence To Patient
606
606
Pain
232
232
Hemorrhage/Bleeding
185
185
Patient Problem/Medical Problem
156
156
Discomfort
126
126
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
122
122
No Patient Involvement
99
99
Unspecified Infection
84
84
Hematuria
35
35
Abrasion
34
34
Blood Loss
33
33
No Code Available
31
31
No Information
29
29
Sepsis
29
29
Irritation
29
29
Burning Sensation
22
22
Injury
16
16
Laceration(s)
16
16
Unspecified Tissue Injury
14
14
Tissue Damage
10
10
Hypersensitivity/Allergic reaction
9
9
Fever
8
8
Urinary Retention
8
8
Tissue Breakdown
8
8
Insufficient Information
8
8
Irritability
7
7
Skin Irritation
7
7
Bacterial Infection
6
6
Skin Tears
5
5
Fungal Infection
4
4
Nausea
4
4
Rash
4
4
Bruise/Contusion
3
3
Headache
3
3
Swelling
3
3
Thrombus
3
3
Vomiting
3
3
Genital Bleeding
3
3
Skin Inflammation/ Irritation
3
3
Confusion/ Disorientation
3
3
Foreign Body In Patient
3
3
Missing Value Reason
2
2
Uterine Perforation
2
2
Abdominal Cramps
2
2
Dysuria
2
2
Hypernatremia
2
2
Hyperglycemia
2
2
Death
2
2
Local Reaction
2
2
Scar Tissue
2
2
Pneumonia
2
2
Inflammation
2
2
Muscle Spasm(s)
2
2
Itching Sensation
1
1
Low Blood Pressure/ Hypotension
1
1
Internal Organ Perforation
1
1
Scarring
1
1
Renal Failure
1
1
Dehydration
1
1
Diarrhea
1
1
Erythema
1
1
Anemia
1
1
Aspiration/Inhalation
1
1
Atrial Fibrillation
1
1
Abdominal Pain
1
1
Cyst(s)
1
1
Foreign Body Sensation in Eye
1
1
Urinary Frequency
1
1
Urticaria
1
1
Obstruction/Occlusion
1
1
Malaise
1
1
Reaction
1
1
Sleep Dysfunction
1
1
Perforation of Vessels
1
1
Chills
1
1
Cramp(s)
1
1
Rupture
1
1
Tachycardia
1
1
Thrombosis
1
1
Septic Shock
1
1
Cancer
1
1
Dementia
1
1
Syncope/Fainting
1
1
Kidney Infection
1
1
Unspecified Kidney or Urinary Problem
1
1
Device Embedded In Tissue or Plaque
1
1
Urinary Incontinence
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Jun-08-2023
2
C.R. Bard, Inc.
II
Apr-04-2018
3
Coloplast Manufacturing US, LLC
II
Jun-03-2011
4
Cure Medical LLC
II
Dec-16-2014
5
Cure Medical LLC
II
Oct-02-2012
6
Wellspect HealthCare (Division of DENTSPLY IH AB)
II
Jul-17-2020
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