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TPLC
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Device
collector, urine, (and accessories) for indwelling catheter
Product Code
KNX
Regulation Number
876.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
190
190
2019
235
235
2020
215
215
2021
223
223
2022
177
177
2023
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Restricted Flow rate
423
423
Deformation Due to Compressive Stress
115
115
No Flow
102
102
Component Missing
72
72
Material Twisted/Bent
57
57
Obstruction of Flow
51
51
Component Misassembled
44
44
Fluid/Blood Leak
42
42
Device Contamination with Chemical or Other Material
33
33
Deflation Problem
31
31
Partial Blockage
27
27
Adverse Event Without Identified Device or Use Problem
27
27
Material Deformation
26
26
Leak/Splash
24
24
Infusion or Flow Problem
23
23
Physical Resistance/Sticking
21
21
Device Operates Differently Than Expected
20
20
Detachment of Device or Device Component
19
19
Improper Flow or Infusion
19
19
Disconnection
19
19
Biocompatibility
18
18
Patient-Device Incompatibility
16
16
Inaccurate Flow Rate
13
13
Backflow
13
13
Inadequate Instructions for Healthcare Professional
10
10
Use of Device Problem
10
10
Expiration Date Error
9
9
Difficult to Remove
9
9
Material Fragmentation
9
9
Break
9
9
Difficult to Open or Close
9
9
Therapeutic or Diagnostic Output Failure
8
8
Complete Blockage
8
8
Kinked
8
8
Misassembled
8
8
Defective Device
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Device Markings/Labelling Problem
7
7
Output Problem
6
6
Appropriate Term/Code Not Available
6
6
Suction Problem
6
6
Labelling, Instructions for Use or Training Problem
6
6
Nonstandard Device
6
6
Incorrect Measurement
6
6
Short Fill
5
5
Device Handling Problem
5
5
Packaging Problem
5
5
Contamination /Decontamination Problem
4
4
Difficult to Open or Remove Packaging Material
4
4
Illegible Information
4
4
Material Split, Cut or Torn
4
4
Inadequacy of Device Shape and/or Size
4
4
Material Puncture/Hole
4
4
Material Too Rigid or Stiff
4
4
Material Rupture
4
4
Insufficient Flow or Under Infusion
4
4
Fungus in Device Environment
4
4
Tear, Rip or Hole in Device Packaging
4
4
Mechanical Problem
4
4
Occlusion Within Device
3
3
Loose or Intermittent Connection
3
3
Inflation Problem
3
3
Contamination
3
3
Defective Component
3
3
Material Separation
3
3
Shipping Damage or Problem
3
3
Material Too Soft/Flexible
3
3
Missing Information
3
3
Failure to Deflate
3
3
Activation Problem
3
3
Gas/Air Leak
3
3
Material Integrity Problem
3
3
Material Protrusion/Extrusion
3
3
Patient Device Interaction Problem
3
3
Inadequate Instructions for Non-Healthcare Professional
2
2
Connection Problem
2
2
Device Operational Issue
2
2
Insufficient Information
2
2
Product Quality Problem
2
2
Delivered as Unsterile Product
2
2
Device Inoperable
2
2
Improper or Incorrect Procedure or Method
2
2
Collapse
2
2
Moisture Damage
2
2
Melted
1
1
Material Opacification
1
1
No Device Output
1
1
Particulates
1
1
Decrease in Pressure
1
1
Increase in Pressure
1
1
Fracture
1
1
Calcified
1
1
Failure to Capture
1
1
Bent
1
1
Loss of or Failure to Bond
1
1
Crack
1
1
Material Discolored
1
1
Filling Problem
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
426
426
No Consequences Or Impact To Patient
407
407
No Known Impact Or Consequence To Patient
366
366
No Patient Involvement
85
85
Urinary Tract Infection
61
61
Pain
23
23
Unspecified Infection
22
22
No Information
19
19
Discomfort
15
15
Urinary Retention
14
14
Insufficient Information
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Patient Problem/Medical Problem
9
9
No Code Available
7
7
Hemorrhage/Bleeding
6
6
Fever
5
5
Hematuria
4
4
Foreign Body In Patient
4
4
Skin Inflammation/ Irritation
3
3
Abrasion
3
3
Muscle Spasm(s)
3
3
Injury
3
3
Pressure Sores
3
3
Skin Irritation
3
3
Swelling
2
2
Sepsis
2
2
Abdominal Pain
2
2
Irritation
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Tissue Breakdown
1
1
Perforation
1
1
Rash
1
1
Scar Tissue
1
1
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Erythema
1
1
Fall
1
1
Head Injury
1
1
Incontinence
1
1
Skin Discoloration
1
1
Burning Sensation
1
1
Chills
1
1
Therapeutic Effects, Unexpected
1
1
Thrombus
1
1
Ulceration
1
1
Distress
1
1
Brain Injury
1
1
Shock, Surgical
1
1
Ulcer
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
III
Jul-15-2019
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